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1.  The Starting Treatment for Ethanol in Primary care Trials (STEP Trials): Protocol for Three Parallel Multi-Site Stepped Care Effectiveness Studies for Unhealthy Alcohol Use in HIV-Positive Patients 
Unhealthy alcohol use is common among HIV-positive patients, yet effective evidence-based treatments are rarely provided in clinical settings providing HIV care. Further, given patient variability in response to initial treatments, stepped care approaches may be beneficial. We describe the rationale, aims and study design for the current Starting Treatment for Ethanol in Primary care Trials (STEP Trials); three parallel randomized controlled effectiveness trials being conducted in five Infectious Disease Clinics. Participants meeting criteria for: 1) at-risk drinking, 2) moderate alcohol use with liver disease (MALD), or 3) alcohol use disorder (AUD) are randomized to integrated stepped care versus treatment as usual. For those with at-risk drinking or MALD, integrated stepped care starts with a one session brief intervention and follow-up 2-week telephone booster. Based on pre-specified nonresponse criteria, participants may be “stepped up” at week 4 to receive four sessions of motivational enhancement therapy (MET) and “stepped up” again at week 12 for addiction physician management (APM) and consideration of alcohol pharmacotherapy. For those with AUD, integrated stepped care begins with APM. Non-responders may be “stepped up” at week 4 to receive MET and again at week 12 for a higher level of care (e.g. intensive outpatient program). The primary outcome is alcohol consumption assessed at 24 weeks, and secondary outcome is the VACS Index, a validated measure of HIV morbidity and mortality risk. Results from the STEP Trials should inform future research and the implementation of interventions to address unhealthy alcohol use among HIV-positive individuals.
PMCID: PMC5253227  PMID: 27876616
Multicenter study; Randomized controlled trial; Algorithms; HIV; Alcohol
2.  Cognitive Behavioral Therapy Improves Treatment Outcomes for Prescription Opioid Users in Primary-Care Based Buprenorphine Treatment 
To determine whether treatment outcomes differed for prescription opioid and heroin use disorder patients, we conducted a secondary analysis of a 24-week (N = 140) randomized trial of Physician Management (PM) or PM plus Cognitive Behavioral Therapy (CBT) in primary care buprenorphine/naloxone treatment. Self-reported opioid use and urine toxicology analyses were obtained weekly. We examined baseline demographic differences between primary prescription opioid use patients (n = 49) and primary heroin use patients (n = 91) and evaluated whether treatment response differed by assigned condition. Compared to primary heroin use patients, primary prescription opioid use patients had marginally fewer years of opioid use, were less likely to have had a previous drug treatment or detoxification, and were less likely to report injection drug use. Although opioid abstinence only, and treatment retention did not differ by opioid use group, opioid category moderated the effect of CBT on urine samples negative for all drugs. Primary prescription opioid use patients assigned to PM-CBT had more than twice the mean number of weeks of abstinence for all drugs (7.6) than those assigned to PM only (3.6; p=.02), while primary heroin use patients did not differ by treatment. Findings suggest that examination of other factors that may predict response to behavioral interventions is warranted.
PMCID: PMC5119533  PMID: 27776678
opioid-related disorders; buprenorphine; cognitive behavioral therapy; treatment outcome
3.  Proceedings of the 14th annual conference of INEBRIA 
Holloway, Aisha S. | Ferguson, Jennifer | Landale, Sarah | Cariola, Laura | Newbury-Birch, Dorothy | Flynn, Amy | Knight, John R. | Sherritt, Lon | Harris, Sion K. | O’Donnell, Amy J. | Kaner, Eileen | Hanratty, Barbara | Loree, Amy M. | Yonkers, Kimberly A. | Ondersma, Steven J. | Gilstead-Hayden, Kate | Martino, Steve | Adam, Angeline | Schwartz, Robert P. | Wu, Li-Tzy | Subramaniam, Geetha | Sharma, Gaurav | McNeely, Jennifer | Berman, Anne H. | Kolaas, Karoline | Petersén, Elisabeth | Bendtsen, Preben | Hedman, Erik | Linderoth, Catharina | Müssener, Ulrika | Sinadinovic, Kristina | Spak, Fredrik | Gremyr, Ida | Thurang, Anna | Mitchell, Ann M. | Finnell, Deborah | Savage, Christine L. | Mahmoud, Khadejah F. | Riordan, Benjamin C. | Conner, Tamlin S. | Flett, Jayde A. M. | Scarf, Damian | McRee, Bonnie | Vendetti, Janice | Gallucci, Karen Steinberg | Robaina, Kate | Clark, Brendan J. | Jones, Jacqueline | Reed, Kathryne D. | Hodapp, Rachel M. | Douglas, Ivor | Burnham, Ellen L. | Aagaard, Laura | Cook, Paul F. | Harris, Brett R. | Yu, Jiang | Wolff, Margaret | Rogers, Meighan | Barbosa, Carolina | Wedehase, Brendan J. | Dunlap, Laura J. | Mitchell, Shannon G. | Dusek, Kristi A. | Gryczynski, Jan | Kirk, Arethusa S. | Oros, Marla T. | Hosler, Colleen | O’Grady, Kevin E. | Brown, Barry S. | Angus, Colin | Sherborne, Sidney | Gillespie, Duncan | Meier, Petra | Brennan, Alan | de Vargas, Divane | Soares, Janaina | Castelblanco, Donna | Doran, Kelly M. | Wittman, Ian | Shelley, Donna | Rotrosen, John | Gelberg, Lillian | Edelman, E. Jennifer | Maisto, Stephen A. | Hansen, Nathan B. | Cutter, Christopher J. | Deng, Yanhong | Dziura, James | Fiellin, Lynn E. | OConnor, Patrick G. | Bedimo, Roger | Gibert, Cynthia | Marconi, Vincent C. | Rimland, David | Rodriguez-Barradas, Maria C. | Simberkoff, Michael S. | Justice, Amy C. | Bryant, Kendall J. | Fiellin, David A. | Giles, Emma L. | Coulton, Simon | Deluca, Paolo | Drummond, Colin | Howel, Denise | McColl, Elaine | McGovern, Ruth | Scott, Stephanie | Stamp, Elaine | Sumnall, Harry | Vale, Luke | Alabani, Viviana | Atkinson, Amanda | Boniface, Sadie | Frankham, Jo | Gilvarry, Eilish | Hendrie, Nadine | Howe, Nicola | McGeechan, Grant J. | Ramsey, Amy | Stanley, Grant | Clephane, Justine | Gardiner, David | Holmes, John | Martin, Neil | Shevills, Colin | Soutar, Melanie | Chi, Felicia W. | Weisner, Constance | Ross, Thekla B. | Mertens, Jennifer | Sterling, Stacy A. | Shorter, Gillian W. | Heather, Nick | Bray, Jeremy | Cohen, Hildie A. | McPherson, Tracy L. | Adam, Cyrille | López-Pelayo, Hugo | Gual, Antoni | Segura-Garcia, Lidia | Colom, Joan | Ornelas, India J. | Doyle, Suzanne | Donovan, Dennis | Duran, Bonnie | Torres, Vanessa | Gaume, Jacques | Grazioli, Véronique | Fortini, Cristiana | Paroz, Sophie | Bertholet, Nicolas | Daeppen, Jean-Bernard | Satterfield, Jason M. | Gregorich, Steven | Alvarado, Nicholas J. | Muñoz, Ricardo | Kulieva, Gozel | Vijayaraghavan, Maya | Adam, Angéline | Cunningham, John A. | Díaz, Estela | Palacio-Vieira, Jorge | Godinho, Alexandra | Kushir, Vladyslav | O’Brien, Kimberly H. M. | Aguinaldo, Laika D. | Sellers, Christina M. | Spirito, Anthony | Chang, Grace | Blake-Lamb, Tiffany | LaFave, Lea R. Ayers | Thies, Kathleen M. | Pepin, Amy L. | Sprangers, Kara E. | Bradley, Martha | Jorgensen, Shasta | Catano, Nico A. | Murray, Adelaide R. | Schachter, Deborah | Andersen, Ronald M. | Rey, Guillermina Natera | Vahidi, Mani | Rico, Melvin W. | Baumeister, Sebastian E. | Johansson, Magnus | Sinadinovic, Christina | Hermansson, Ulric | Andreasson, Sven | O’Grady, Megan A. | Kapoor, Sandeep | Akkari, Cherine | Bernal, Camila | Pappacena, Kristen | Morley, Jeanne | Auerbach, Mark | Neighbors, Charles J. | Kwon, Nancy | Conigliaro, Joseph | Morgenstern, Jon | Magill, Molly | Apodaca, Timothy R. | Borsari, Brian | Hoadley, Ariel | Scott Tonigan, J. | Moyers, Theresa | Fitzgerald, Niamh M. | Schölin, Lisa | Barticevic, Nicolas | Zuzulich, Soledad | Poblete, Fernando | Norambuena, Pablo | Sacco, Paul | Ting, Laura | Beaulieu, Michele | Wallace, Paul George | Andrews, Matthew | Daley, Kate | Shenker, Don | Gallagher, Louise | Watson, Rod | Weaver, Tim | Bruguera, Pol | Oliveras, Clara | Gavotti, Carolina | Barrio, Pablo | Braddick, Fleur | Miquel, Laia | Suárez, Montse | Bruguera, Carla | Brown, Richard L. | Capell, Julie Whelan | Paul Moberg, D. | Maslowsky, Julie | Saunders, Laura A. | McCormack, Ryan P. | Scheidell, Joy | Gonzalez, Mirelis | Bauroth, Sabrina | Liu, Weiwei | Lindsay, Dawn L. | Lincoln, Piper | Hagle, Holly | Wallhed Finn, Sara | Hammarberg, Anders | Andréasson, Sven | King, Sarah E. | Vargo, Rachael | Kameg, Brayden N. | Acquavita, Shauna P. | Van Loon, Ruth Anne | Smith, Rachel | Brehm, Bonnie J. | Diers, Tiffiny | Kim, Karissa | Barker, Andrea | Jones, Ashley L. | Skinner, Asheley C. | Hinman, Agatha | Svikis, Dace S. | Thacker, Casey L. | Resnicow, Ken | Beatty, Jessica R. | Janisse, James | Puder, Karoline | Bakshi, Ann-Sofie | Milward, Joanna M. | Kimergard, Andreas | Garnett, Claire V. | Crane, David | Brown, Jamie | West, Robert | Michie, Susan | Rosendahl, Ingvar | Andersson, Claes | Gajecki, Mikael | Blankers, Matthijs | Donoghue, Kim | Lynch, Ellen | Maconochie, Ian | Phillips, Ceri | Pockett, Rhys | Phillips, Tom | Patton, R. | Russell, Ian | Strang, John | Stewart, Maureen T. | Quinn, Amity E. | Brolin, Mary | Evans, Brooke | Horgan, Constance M. | Liu, Junqing | McCree, Fern | Kanovsky, Doug | Oberlander, Tyler | Zhang, Huan | Hamlin, Ben | Saunders, Robert | Barton, Mary B. | Scholle, Sarah H. | Santora, Patricia | Bhatt, Chirag | Ahmed, Kazi | Hodgkin, Dominic | Gao, Wenwu | Merrick, Elizabeth L. | Drebing, Charles E. | Larson, Mary Jo | Sharma, Monica | Petry, Nancy M. | Saitz, Richard | Weisner, Constance M. | Young-Wolff, Kelly C. | Lu, Wendy Y. | Blosnich, John R. | Lehavot, Keren | Glass, Joseph E. | Williams, Emily C. | Bensley, Kara M. | Chan, Gary | Dombrowski, Julie | Fortney, John | Rubinsky, Anna D. | Lapham, Gwen T. | Forray, Ariadna | Olmstead, Todd A. | Gilstad-Hayden, Kathryn | Kershaw, Trace | Dillon, Pamela | Weaver, Michael F. | Grekin, Emily R. | Ellis, Jennifer D. | McGoron, Lucy | McGoron, Lucy
PMCID: PMC5606215
4.  An Analysis of Moderators in the COMBINE Study: Identifying Subgroups of Patients Who Benefit from Acamprosate 
The goal of the current study was to use tree-based methods to identify moderators of acamprosate effect on abstinence from heavy drinking in COMBINE, the largest study of pharmacotherapy for alcoholism in the United States to date. We used three different tree-based methods for identification of subgroups with enhanced treatment response on acamprosate based on over 100 predictors measured at baseline in COMBINE. No heavy drinking during the last two months of treatment was the considered outcome. All three methods identified consecutive days of abstinence prior to treatment as the most important moderator of treatment effect. Acamprosate was beneficial for participants with shorter abstinence (1 week or less) especially when body mass index was low or normal. In this group, 46% of participants receiving active acamprosate abstained from heavy drinking compared to 23% of those receiving placebo acamprosate. Prior treatment, age, drinking goal and cognitive inefficiency were identified as moderators of acamprosate effects by one of the three methods. In conclusion, acamprosate may be beneficial for participants with shorter abstinence who are not overweight or obese. One hypothesis for this finding is that this subgroup may have greater glutamatergic hyperactivity, a target of acamprosate, and may achieve better drug plasma levels based on their lower BMI. In contrast, those with extended pretreatment abstinence who have an otherwise good prognosis did not benefit from acamprosate. Further validation of the results in independent data sets is necessary.
PMCID: PMC4600651  PMID: 26141511
alcohol dependence; moderator effects; classification and regression trees; subgroups with enhanced treatment effect; clinical trials
5.  Proceedings of the 13th annual conference of INEBRIA 
Watson, Rod | Morris, James | Isitt, John | Barrio, Pablo | Ortega, Lluisa | Gual, Antoni | Conner, Kenneth | Stecker, Tracy | Maisto, Stephen | Paroz, Sophie | Graap, Caroline | Grazioli, Véronique S | Daeppen, Jean-Bernard | Collins, Susan E | Bertholet, Nicolas | McNeely, Jennifer | Kushnir, Vlad | Cunningham, John A. | Crombie, Iain K | Cunningham, Kathryn B | Irvine, Linda | Williams, Brian | Sniehotta, Falko F | Norrie, John | Melson, Ambrose | Jones, Claire | Briggs, Andrew | Rice, Peter | Achison, Marcus | McKenzie, Andrew | Dimova, Elena | Slane, Peter W | Grazioli, Véronique S. | Collins, Susan E. | Paroz, Sophie | Graap, Caroline | Daeppen, Jean-Bernard | Baggio, Stéphanie | Dupuis, Marc | Studer, Joseph | Gmel, Gerhard | Magill, Molly | Grazioli, Véronique S. | Tait, Robert J. | Teoh, Lucinda | Kelty, Erin | Geelhoed, Elizabeth | Mountain, David | Hulse, Gary K. | Renko, Elina | Mitchell, Shannon G. | Lounsbury, David | Li, Zhi | Schwartz, Robert P. | Gryczynski, Jan | Kirk, Arethusa S. | Oros, Marla | Hosler, Colleen | Dusek, Kristi | Brown, Barry S. | Finnell, Deborah S. | Holloway, Aisha | Wu, Li-Tzy | Subramaniam, Geetha | Sharma, Gaurav | Wallhed Finn, Sara | Andreasson, Sven | Dvorak, Robert D. | Kramer, Matthew P. | Stevenson, Brittany L. | Sargent, Emily M. | Kilwein, Tess M. | Harris, Sion K. | Sherritt, Lon | Copelas, Sarah | Knight, John R. | Mdege, Noreen D | McCambridge, Jim | Bischof, Gallus | Bischof, Anja | Freyer-Adam, Jennis | Rumpf, Hans-Juergen | Fitzgerald, Niamh | Schölin, Lisa | Toner, Paul | Böhnke, Jan R. | Veach, Laura J. | Currin, Olivia | Dongre, Leigh Z. | Miller, Preston R. | White, Elizabeth | Williams, Emily C. | Lapham, Gwen T. | Bobb, Jennifer J. | Rubinsky, Anna D. | Catz, Sheryl L. | Shortreed, Susan | Bensley, Kara M. | Bradley, Katharine A. | Milward, Joanna | Deluca, Paolo | Khadjesari, Zarnie | Watson, Rod | Fincham-Campbell, Stephanie | Drummond, Colin | Angus, Kathryn | Bauld, Linda | Baumann, Sophie | Haberecht, Katja | Schnuerer, Inga | Meyer, Christian | Rumpf, Hans-Jürgen | John, Ulrich | Gaertner, Beate | Barrault-Couchouron, Marion | Béracochéa, Marion | Allafort, Vincent | Barthélémy, Valérie | Bonnefoi, Hervé | Bussières, Emmanuel | Garguil, Véronique | Auriacombe, Marc | Saint-Jacques, Marianne | Dorval, Michel | M’Bailara, Katia | Segura-Garcia, Lidia | Ibañez-Martinez, Nuria | Mendive-Arbeloa, Juan Manuel | Anoro-Perminger, Manel | Diaz-Gallego, Pako | Piñar-Mateos, Mª Angeles | Colom-Farran, Joan | Deligianni, Marianthi | Yersin, Bertrand | Adam, Angeline | Weisner, Constance | Chi, Felicia | Lu, Wendy | Sterling, Stacy | Kraemer, Kevin L. | McGinnis, Kathleen A. | Fiellin, David A. | Skanderson, Melissa | Gordon, Adam J. | Robbins, Jonathan | Zickmund, Susan | Korthuis, P. Todd | Edelman, E. Jennifer | Hansen, Nathan B. | Cutter, Christopher J. | Dziura, James | Fiellin, Lynn E. | OConnor, Patrick G. | Maisto, Stephen A. | Bedimo, Roger | Gilbert, Cynthia | Marconi, Vincent C. | Rimland, David | Rodriguez-Barradas, Maria | Simberkoff, Michael | Justice, Amy C. | Bryant, Kendall J. | Berman, Anne H | Shorter, Gillian W | Bray, Jeremy W | Barbosa, Carolina | Johansson, Magnus | Hester, Reid | Campbell, William | Souza Formigoni, Maria Lucia O. | Andrade, André Luzi Monezi | Sartes, Laisa Marcorela Andreoli | Sundström, Christopher | Eék, Niels | Kraepelien, Martin | Kaldo, Viktor | Fahlke, Claudia | Hernandez, Lynn | Becker, Sara J. | Jones, Richard N. | Graves, Hannah R. | Spirito, Anthony | Diestelkamp, Silke | Wartberg, Lutz | Arnaud, Nicolas | Thomasius, Rainer | Gaume, Jacques | Grazioli, Véronique | Fortini, Cristiana | Malan, Zelra | Mash, Bob | Everett-Murphy, Katherine | Grazioli, Véronique S. | Studer, Joseph | Mohler-Kuo, M. | Bertholet, Nicolas | Gmel, Gerhard | Doi, Lawrence | Cheyne, Helen | Jepson, Ruth | Luna, Vanesa | Echeverria, Leticia | Morales, Silvia | Barroso, Teresa | Abreu, Ângela | Aguiar, Cosma | Stewart, Duncan | Abreu, Angela | Brites, Riany M. | Jomar, Rafael | Marinho, Gerson | Parreira, Pedro | Seale, J. Paul | Johnson, J. Aaron | Henry, Dena | Chalmers, Sharon | Payne, Freida | Tuck, Linda | Morris, Akula | Gonçalves, Cátia | Besser, Bettina | Casajuana, Cristina | López-Pelayo, Hugo | Balcells, María Mercedes | Teixidó, Lídia | Miquel, Laia | Colom, Joan | Hepner, Kimberly A. | Hoggatt, Katherine. J. | Bogart, Andy | Paddock, Susan. M. | Hardoon, Sarah L | Petersen, Irene | Hamilton, Fiona L | Nazareth, Irwin | White, Ian R. | Marston, Louise | Wallace, Paul | Godfrey, Christine | Murray, Elizabeth | Sovinová, Hana | Csémy, Ladislav
PMCID: PMC5032602  PMID: 27654147
6.  Overdose Education and Naloxone Rescue Kits for Family Members of Opioid Users: Characteristics, Motivations and Naloxone Use 
Substance abuse  2015;36(2):149-154.
In response to the overdose epidemic, a network of support groups for family members in Massachusetts has been providing overdose education and naloxone rescue kits (OEN). The aims of this study were to describe the characteristics, motivations and benefits of family members who receive OEN and to describe the frequency of naloxone used during an overdose rescue.
This cross-sectional, multisite study surveyed attendees of community support groups for family members of opioid users where OEN training was offered using a 42 item self-administered survey that included demographics, relationship to opioid user, experience with overdose, motivations to receive OEN, and naloxone rescue kit use.
Of 126 attendees who completed surveys at 8 sites, most attendees were white (95%), female (78%), married or partnered (74%), parents of an opioid user (85%), and provide financial support for opioid user (52%). The OEN trainees (79%) were more likely than attendees not trained (21%) to be parents of an opioid user (91% v 65%, p <0.05), provide financial support to an opioid user (58% v 30%, p <0.05), and to have witnessed an overdose (35% v 12%, p=0.07). The major motivations to receive training were: wanting a kit in their home (72%), education provided at the meeting (60%) and hearing about benefits from others (57%). Sixteen parents reported witnessing their child overdose and five attendees had used naloxone successfully during an overdose rescue.
Support groups for families of people who use opioids are promising venues to conduct overdose prevention trainings, because attendees are motivated to receive training and will use naloxone to rescue people when witnessing an overdose. Further study is warranted to understand how to optimize this approach to overdose prevention in the community setting.
PMCID: PMC4809347  PMID: 25564892
7.  Implementation of integrated stepped care for unhealthy alcohol use in HIV clinics 
Effective counseling and pharmacotherapy for unhealthy alcohol use are rarely provided in HIV treatment settings to patients. Our goal was to describe factors influencing implementation of a stepped care model to address unhealthy alcohol use in HIV clinics from the perspectives of social workers, psychologists and addiction psychiatrists.
We conducted two focus groups with Social Workers (n = 4), Psychologists (n = 2), and Addiction Psychiatrists (n = 4) involved in an ongoing randomized controlled trial evaluating the effectiveness of integrated stepped care for unhealthy alcohol use in HIV-infected patients at five Veterans Health Administration (VA) HIV clinics. Data collection and analyses were guided by the Consolidated Framework for Implementation Research (CFIR) domains, with a focus on the three domains which we considered to be most relevant: intervention characteristics (i.e. motivational interviewing, pharmacotherapy), the inner setting (i.e. HIV clinics), and characteristics of individuals (i.e. the providers). A multidisciplinary team used directed content analysis to identify major themes.
From the providers’ perspective, the major implementation themes that emerged by CFIR domain included: (1) Intervention characteristics: providers valued tools and processes for facilitating patient motivation for treatment of unhealthy alcohol use given their perceived lack of motivation, but expressed a desire for greater flexibility; (2) Inner setting: treating unhealthy alcohol use in HIV clinics was perceived by providers to be consistent with VA priorities; and (3) Characteristics of individuals: there was high self-efficacy to conduct the intervention, an expressed need for more consistent utilization to maintain skills, and consideration of alternative models for delivering the components of the intervention.
Use of the CFIR framework reveals that implementation of integrated stepped care for unhealthy alcohol use in HIV clinics is facilitated by tools to help providers enhance patient motivation or address unhealthy alcohol use among patients perceived to be unmotivated. Implementation may be facilitated by its consistency with organizational values and existing models of care and attention to optimizing provider self-efficacy and roles (i.e. approaches to treatment integration).
PMCID: PMC4711105  PMID: 26763048
HIV; Alcohol-related disorders; Qualitative methods; Diffusion of innovation
8.  Emergency Department–Initiated Buprenorphine/Naloxone Treatment for Opioid Dependence 
JAMA  2015;313(16):1636-1644.
Opioid-dependent patients often use the emergency department (ED) for medical care.
To test the efficacy of 3 interventions for opioid dependence: (1) screening and referral to treatment (referral); (2) screening, brief intervention, and facilitated referral to community-based treatment services (brief intervention); and (3) screening, brief intervention, ED-initiated treatment with buprenorphine/naloxone, and referral to primary care for 10-week follow-up (buprenorphine).
A randomized clinical trial involving 329 opioid-dependent patients who were treated at an urban teaching hospital ED from April 7, 2009, through June 25, 2013.
After screening, 104 patients were randomized to the referral group, 111 to the brief intervention group, and 114 to the buprenorphine treatment group.
Enrollment in and receiving addiction treatment 30 days after randomization was the primary outcome. Self-reported days of illicit opioid use, urine testing for illicit opioids, human immunodeficiency virus (HIV) risk, and use of addiction treatment services were the secondary outcomes.
Seventy-eight percent of patients in the buprenorphine group (89 of 114 [95% CI, 70%-85%]) vs 37% in the referral group (38 of 102 [95% CI, 28%-47%]) and 45% in the brief intervention group (50 of 111 [95% CI, 36%-54%]) were engaged in addiction treatment on the 30th day after randomization (P < .001). The buprenorphine group reduced the number of days of illicit opioid use per week from 5.4 days (95% CI, 5.1-5.7) to 0.9 days (95% CI, 0.5-1.3) vs a reduction from 5.4 days (95% CI, 5.1-5.7) to 2.3 days (95% CI, 1.7-3.0) in the referral group and from 5.6 days (95% CI, 5.3-5.9) to 2.4 days (95% CI, 1.8-3.0) in the brief intervention group (P < .001 for both time and intervention effects; P = .02 for the interaction effect). The rates of urine samples that tested negative for opioids did not differ statistically across groups, with 53.8% (95% CI, 42%-65%) in the referral group, 42.9% (95% CI, 31%-55%) in the brief intervention group, and 57.6% (95% CI, 47%-68%) in the buprenorphine group (P = .17). There were no statistically significant differences in HIV risk across groups (P = .66). Eleven percent of patients in the buprenorphine group (95% CI, 6%-19%) used inpatient addiction treatment services, whereas 37% in the referral group (95% CI, 27%-48%) and 35% in the brief intervention group (95% CI, 25%-37%) used inpatient addiction treatment services (P < .001).
Among opioid-dependent patients, ED-initiated buprenorphine treatment vs brief intervention and referral significantly increased engagement in addiction treatment, reduced self-reported illicit opioid use, and decreased use of inpatient addiction treatment services but did not significantly decrease the rates of urine samples that tested positive for opioids or of HIV risk. These findings require replication in other centers before widespread adoption.
TRIAL REGISTRATION Identifier: NCT00913770
PMCID: PMC4527523  PMID: 25919527
9.  Predictors of Abstinence from Heavy Drinking During Treatment in COMBINE and External Validation in PREDICT 
The goal of the current study was to use tree-based methods (Zhang and Singer, 2010) to identify predictors of abstinence from heavy drinking in COMBINE (Anton et al., 2006), the largest study of pharmacotherapy for alcoholism in the United States to date, and to validate these results in PREDICT (Mann et al., 2012), a parallel study conducted in Germany.
We compared a classification tree constructed according to purely statistical criteria to a tree constructed according to a combination of statistical criteria and clinical considerations for prediction of no heavy drinking during treatment in COMBINE. We considered over one-hundred baseline predictors. The tree approach was compared to logistic regression. The trees and a deterministic forest identified the most important predictors of no heavy drinking for direct testing in PREDICT.
The tree built using both clinical and statistical considerations consisted of four splits based on consecutive days of abstinence (CDA) prior to randomization, age, family history of alcoholism (FHAlc) and confidence to resist drinking in response to withdrawal and urges. The tree based on statistical considerations with four splits also split on CDA and age but also on GGT level and drinking goal. Deterministic forest identified CDA, age and drinking goal as the most important predictors. Backward elimination logistic regression among the top 18 predictors identified in the deterministic forest analyses identified only age and CDA as significant main effects. Longer CDA and goal of complete abstinence were associated with better outcomes in both data sets.
The most reliable predictors of abstinence from heavy drinking were CDA and drinking goal. Trees provide binary decision rules and straightforward graphical representations for identification of subgroups based on response and may be easier to implement in clinical settings.
PMCID: PMC4397985  PMID: 25346505
alcohol dependence; clinical trial; classification tree; deterministic forest; logistic regression
10.  Opioid Detoxification and Naltrexone Induction Strategies: Recommendations for Clinical Practice 
Opioid dependence is a significant public health problem associated with high risk for relapse if treatment is not ongoing. While maintenance on opioid agonists (i.e., methadone, buprenorphine) often produces favorable outcomes, detoxification followed by treatment with the μ-opioid receptor antagonist naltrexone may offer a potentially useful alternative to agonist maintenance for some patients.
Treatment approaches for making this transition are described here based on a literature review and solicitation of opinions from several expert clinicians and scientists regarding patient selection, level of care, and detoxification strategies.
Among the current detoxification regimens, the available clinical and scientific data suggest that the best approach may be using an initial 2–4 mg dose of buprenorphine combined with clonidine, other ancillary medications, and progressively increasing doses of oral naltrexone over 3–5 days up to the target dose of naltrexone. However, more research is needed to empirically validate the best approach for making this transition.
PMCID: PMC4331107  PMID: 22404717
opioid dependence; detoxification; taper; naltrexone; naloxone; buprenorphine; methadone
11.  Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain 
Use of chronic opioid therapy for chronic noncancer pain has increased substantially. The American Pain Society and the American Academy of Pain Medicine commissioned a systematic review of the evidence on chronic opioid therapy for chronic noncancer pain and convened a multidisciplinary expert panel to review the evidence and formulate recommendations. Although evidence is limited, the expert panel concluded that chronic opioid therapy can be an effective therapy for carefully selected and monitored patients with chronic noncancer pain. However, opioids are also associated with potentially serious harms, including opioid-related adverse effects and outcomes related to the abuse potential of opioids. The recommendations presented in this document provide guidance on patient selection and risk stratification; informed consent and opioid management plans; initiation and titration of chronic opioid therapy; use of methadone; monitoring of patients on chronic opioid therapy; dose escalations, high-dose opioid therapy, opioid rotation, and indications for discontinuation of therapy; prevention and management of opioid-related adverse effects; driving and work safety; identifying a medical home and when to obtain consultation; management of breakthrough pain; chronic opioid therapy in pregnancy; and opioid-related polices. Perspective: Safe and effective chronic opioid therapy for chronic noncancer pain requires clinical skills and knowledge in both the principles of opioid prescribing and on the assessment and management of risks associated with opioid abuse, addiction, and diversion. Although evidence is limited in many areas related to use of opioids for chronic noncancer pain, this guideline provides recommendations developed by a multidisciplinary expert panel following a systematic review of the evidence.
PMCID: PMC4043401  PMID: 19187889
clinical practice guideline; opioids; opioid analgesics; risk assessment; monitoring; chronic pain
12.  A Randomized Trial of Cognitive Behavioral Therapy in Primary Care-based Buprenorphine 
The American journal of medicine  2013;126(1):74.e11-74.e17.
To determine the impact of cognitive behavioral therapy on outcomes in primary care, office-based buprenorphine/naloxone treatment of opioid dependence.
We conducted a 24-week randomized clinical trial in 141 opioid-dependent patients in a primary care clinic. Patients were randomized to physician management or physician management plus cognitive behavioral therapy. Physician management was brief, manual guided, and medically focused; cognitive behavioral therapy was manual guided and provided for the first 12 weeks of treatment. The primary outcome measures were self-reported frequency of illicit opioid use and the maximum number of consecutive weeks of abstinence from illicit opioids, as documented by urine toxicology and self-report.
The 2 treatments had similar effectiveness with respect to reduction in the mean self-reported frequency of opioid use, from 5.3 days per week (95% confidence interval, 5.1–5.5) at baseline to 0.4 (95% confidence interval, 0.1–0.6) for the second half of maintenance (P<.001 for the comparisons of induction and maintenance with baseline), with no differences between the 2 groups (P=.96) or between the treatments over time (P=.44). For the maximum consecutive weeks of opioid abstinence there was a significant main effect of time (P<.001), but the interaction (P=.11) and main effect of group (P=.84) were not significant. No differences were observed on the basis of treatment assignment with respect to cocaine use or study completion.
Among patients receiving buprenorphine/naloxone in primary care for opioid dependence, the effectiveness of physician management did not differ significantly from that of physician management plus cognitive behavioral therapy.
PMCID: PMC3621718  PMID: 23260506
Analgesics; Buprenorphine; Cognitive therapy; Opioid; Opioid-related Disorders; Primary health care
13.  Drug Treatment Outcomes among HIV-Infected Opioid Dependent Patients Receiving Buprenorphine/naloxone 
Journal of acquired immune deficiency syndromes (1999)  2011;56(0 1):10.1097/QAI.0b013e3182097537.
Buprenorphine/naloxone allows the integration of opioid dependence and HIV treatment.
We conducted a prospective study in HIV-infected opioid dependent patients to investigate the impact of buprenorphine/naloxone treatment on drug use. Self-report and chart review assessments were conducted every 3 months (Quarters 1 through 4) for one year. Outcomes were buprenorphine/naloxone treatment retention, drug use, and addiction treatment processes.
Among 303 patients enrolled between July 2005 and December 2007, retention in buprenorphine/naloxone treatment was 74%, 67%, 59% and 49% during Quarters 1,2 3, and 4, respectively. Past 30 day illicit opioid use decreased from 84% of patients at baseline to 42% in retained patients over the year. Patients were 52% less likely to use illicit opioids for each quarter in treatment (OR = .66; 95% CI 0.61–0.72). Buprenorphine/naloxone doses and office visits approximated guidelines published by the United States Department of Health and Human Services. Urine toxicology monitoring was less frequent than recommended.
Buprenorphine/naloxone provided in HIV treatment settings can decrease opioid use. Strategies are needed to improve retention and address ongoing drug use in this treatment population.
PMCID: PMC3863630  PMID: 21317592
Buprenorphine; heroin dependence; opioid-related disorders; HIV; methadone
14.  Development of a Scale to Measure Practitioner Adherence to a Brief Intervention in the Emergency Department 
Brief intervention (BI) can reduce harmful and hazardous drinking among emergency department patients. However, no psychometrically-validated instrument for evaluating the extent to which practitioners correctly implement BIs in clinical practice (e.g., adherence) exists. We developed and subsequently examined the psychometric properties of a scale that measures practitioner adherence to a BI, namely the Brief Negotiation Interview (BNI). Ratings of 342 audio-taped BIs in the emergency department demonstrated that the BNI Adherence Scale (BAS) has: 1) excellent internal consistency and discriminant validity; 2) good to excellent inter-rater reliability, and 3) good construct validity, with an 8-item, 2-factor structure accounting for 62% of the variance, but 4) no predictive validity in this study. The BAS provides practitioners with a brief, objective method to evaluate their BNI skills and give feedback to them about their performance.
PMCID: PMC3661016  PMID: 23021098
Brief Intervention; Practitioner Adherence; Harmful and Hazardous Drinking; Emergency Department; Assessment; Psychometrics
15.  A Brief Intervention Reduces Hazardous and Harmful Drinking in Emergency Department Patients 
Annals of emergency medicine  2012;60(2):10.1016/j.annemergmed.2012.02.006.
Brief interventions (BI) have been shown to reduce alcohol use and improve outcomes in Hazardous and Harmful (HH) drinkers but evidence to support their use in emergency department (ED) patients is limited. The use of research assessments in studies of BI may contribute to uncertainty about their effectiveness.
We randomized 889 adult ED patients with HH drinking. A total of 740 received 1) an emergency practitioner (EP)-performed Brief Negotiation Interview (BNI, n=297), 2) BNI with a 1-month follow-up telephone booster (BNI with Booster), (n=295), or 3) standard care (SC, n=148). We also included a standard care with no assessments (SC-NA, n=149) group to examine the impact of assessments on drinking outcomes. Primary outcomes analyzed using mixed models procedures included past 7-day alcohol consumption and 28-day binge episodes at 6 and 12 months collected by Interactive Voice Response. Secondary outcomes included negative health behaviors and consequences collected by phone surveys.
The reduction in mean number of drinks in the past 7 days from baseline to 6 and 12 months was significantly greater in BNI with Booster: from 20.4 (95% confidence interval [CI], 18.8-22.0) to 11.6 (95% CI, 9.7-13.5) to 13.0 (95% CI, 10.5-15.5) and BNI: from 19.8 (95% CI, 18.3-21.4) to 12.7 (95% CI, 10.8-14.6), to 14.3 (95% CI, 11.9-16.8), than in SC: from 20.9 (95% CI, 18.7-23.2) to 14.2 (95% CI, 11.2-17.1), to 17.6 (95% CI, 14.1-21.2). The reduction in 28-day binge episodes was also greater in BNI with Booster: from 7.5 (95% CI, 6.8-8.2) to 4.4 (95% CI, 3.6-5.2) to 4.7 (95% CI, 3.9-5.6) and in BNI: from 7.2 (95% CI, 6.5-7.9) to 4.8 (95% CI, 4.0-5.6), to 5.1 (95% CI, 4.2-5.9), than in SC: from 7.2 (95% CI, 6.2-8.2) to 5.7 (95% CI, 4.5-6.9), to 5.8 (95% CI, 4.6-7.0). BNI with Booster offered no significant benefit over BNI. There were no differences in drinking outcomes between the SC and SC-NA groups. The reductions in rates of driving after drinking ≥ 3 drinks from baseline to 12 months were greater in the BNI (38% to 29%) and BNI with Booster (39% to 31%) groups than in the SC group (43% to 42%).
EP-performed brief interventions can reduce alcohol consumption and episodes of driving after drinking in HH drinkers. These results support the use of brief interventions in ED settings.
PMCID: PMC3811141  PMID: 22459448
Alcohol drinking; psychotherapy brief; emergency service; hospital; emergency medical services
16.  Counseling and directly observed medication for primary care buprenorphine/naloxone maintenance: A pilot study 
Journal of addiction medicine  2012;6(3):205-211.
Counseling and medication adherence can affect opioid agonist treatment outcomes. We investigated the impact of two counseling intensities and two medication dispensing methods in patients receiving buprenorphine (BUP) in primary care.
In a 12-week trial, patients were assigned to Physician Management (PM) with weekly BUP dispensing (n = 28) vs. PM and directly observed, thrice-weekly BUP and cognitive behavioral therapy (PM+DOT/CBT; n = 27) based on therapist availability. Fifteen minute PM visits were provided at entry, after induction and then monthly. CBT was weekly 45-minute sessions provided by trained therapists.
Treatment groups differed on baseline characteristics of years of opioid use, history of detoxification from opioids, and opioid negative urines during induction. Analyses adjusting for baseline characteristics showed no significant differences between groups on retention or drug use based on self-report or urines. Patient satisfaction was high across conditions, indicating acceptability of CBT counseling with observed medication. The number of CBT sessions attended was significantly associated with improved outcome, and session attendance was associated with a greater abstinence the following week.
Although the current findings were non-significant, DOT plus individual CBT sessions was feasible and acceptable to patients. Additional research evaluating the independent effect of directly observed medication and CBT counseling is needed.
PMCID: PMC3419276  PMID: 22614936
Buprenorphine/Therapeutic Use; Primary Health Care; Opioid Related Disorders
17.  Targeting Behavioral Therapies to Enhance Naltrexone Treatment of Opioid Dependence 
Archives of general psychiatry  2001;58(8):755-761.
Contingency management (CM) and significant other involvement (SO) were evaluated as strategies to enhance treatment retention, medication compliance, and outcome for naltrexone treatment of opioid dependence.
One hundred twenty-seven recently detoxified opioid-dependent individuals were randomly assigned to 1 of 3 conditions delivered for 12 weeks: (1) standard naltrexone treatment, given 3 times a week; (2) naltrexone treatment plus contingency management (CM), with delivery of vouchers contingent on naltrexone compliance and drug-free urine specimens; or (3) naltrexone treatment, CM, plus significant other involvement (SO), where a family member was invited to participate in up to 6 family counseling sessions. Principal outcomes were retention in treatment, compliance with naltrexone therapy, and number of drug-free urine specimens.
First, CM was associated with significant improvements in treatment retention (7.4 vs 5.6 weeks; P=.05) and in reduction in opioid use (19 vs 14 opioid-free urine specimens; P=.04) compared with standard naltrexone treatment. Second, assignment to SO did not significantly improve retention, compliance, or substance abuse outcomes compared with CM. Significant effects for the SO condition over CM on retention, compliance, and drug use outcomes were seen only for the subgroup who attended at least 1 family counseling session. The SO condition was associated with significant (P=.02) improvements in family functioning.
Behavioral therapies, such as CM, can be targeted to address weaknesses of specific pharmacotherapies, such as noncompliance, and thus can play a substantial role in broadening the utility of available pharmacotherapies.
PMCID: PMC3651594  PMID: 11483141
18.  The impact of cocaine use on outcomes in HIV-infected patients receiving buprenorphine/naloxone 
Cocaine use is common in opioid dependent HIV-infected patients but its impact on treatment outcomes in these patients receiving buprenorphine/naloxone is not known.
We conducted a prospective study in 299 patients receiving buprenorphine/naloxone who provided baseline cocaine data and a subset of 266 patients who remained in treatment for greater than or equal to one quarter. Assessments were conducted at baseline and quarterly for one year. We evaluated the association between baseline and in-treatment cocaine use on buprenorphine/naloxone retention, illicit opioid use, antiretroviral adherence, CD4 counts, HIV RNA, and risk behaviors.
Sixty-six percent (197/299) of patients reported baseline cocaine use and 65% (173/266) of patients with follow-up data reported in-treatment cocaine use. Baseline and in-treatment cocaine use did not impact buprenorphine/naloxone retention, antiretroviral adherence, CD4 lymphocytes, or HIV risk behaviors. However, baseline cocaine use was associated with a 14.8 (95% CI=9.0–24.2) times greater likelihood of subsequent cocaine use (95% CI=9.0 – 24.2), a 1.4 (95% CI=1.02 – 2.00) times greater likelihood of subsequent opioid use, and higher Log10 HIV RNA (p≤ .016) over time. In-treatment cocaine use was associated with a 1.4 (95% CI=1.01–2.00) times greater likelihood of concurrent opioid use.
Given cocaine use negatively impacts opioid and HIV treatment outcomes, interventions to address cocaine use in HIV-infected patients receiving buprenorphine/naloxone treatment are warranted.
PMCID: PMC3065971  PMID: 21317595
Cocaine; HIV; Buprenorphine; heroin dependence; opioid-related disorders
19.  Opioids, Chronic Pain, and Addiction in Primary Care 
Research has largely ignored the systematic examination of physicians’ attitudes towards providing care for patients with chronic non-cancer pain. The objective of this study was to identify barriers and facilitators to opioid treatment of chronic non-cancer pain patients by office-based medical providers. We used a qualitative study design using individual and group interviews. Participants were twenty-three office-based physicians in New England. Interviews were audiotaped, transcribed, and systematically coded by a multidisciplinary team using the constant comparative method. Physician barriers included lack of expertise in the treatment of chronic pain and co-existing disorders, including addiction; lack of interest in pain management; patients’ aberrant behaviors; and physicians’ attitudes toward prescribing opioid analgesics. Physician facilitators included promoting continuity of patient care and the use of opioid agreements. Physicians’ perceptions of patient-related barriers included lack of physician responsiveness to patients’ pain reports, negative attitudes toward opioid analgesics, concerns about cost, and patients’ low motivation for pain treatment. Perceived logistical barriers included lack of appropriate pain management and addiction referral options, limited information regarding diagnostic workup, limited insurance coverage for pain management services, limited ancillary support for physicians, and insufficient time. Addressing these barriers to pain treatment will be crucial to improving pain management service delivery.
PMCID: PMC2955997  PMID: 20627817
Chronic pain; opioid-related disorders; qualitative research; physicians
20.  The Association between Cocaine Use and Treatment Outcomes in Patients Receiving Office-Based Buprenorphine/Naloxone for the Treatment of Opioid Dependence 
Cocaine use in patients receiving methadone is associated with worse treatment outcomes. The association between cocaine use and office-based buprenorphine/naloxone treatment outcomes is not known. We evaluated the association between baseline and in-treatment cocaine use, treatment retention and urine toxicology results in 162 patients enrolled in a 24-week trial of primary care office-based buprenorphine/naloxone maintenance. Patients with baseline cocaine metabolite-negative urine toxicology tests compared with those with cocaine metabolite-positive tests had more mean weeks of treatment retention (18.3 vs. 15.8, p=.04), a greater percentage completed 24 weeks of treatment (50% vs. 33%, p=.04) and had a greater percentage of opioid-negative urines (47% vs. 34%, p=.02). Patients with in- treatment cocaine metabolite-negative urine toxicology tests compared with cocaine metabolite-positive patients had more mean weeks of treatment retention (19.0 vs. 16.5, p=.003), a greater percentage completed 24 weeks of treatment (60% vs. 30%, p<.001), and had a greater percentage of opioid-negative urines (51% vs. 35%, p=.001). We conclude that both baseline and in-treatment cocaine use is associated with worse treatment outcomes in patients receiving office-based buprenorphine/naloxone and may benefit from targeted interventions.
PMCID: PMC3107713  PMID: 20132122
21.  Medications for Unhealthy Alcohol Use 
Alcohol Research & Health  2011;33(4):300-312.
The prevalence of unidentified or untreated unhealthy alcohol use remains high. With the advent of pharmacotherapy and models of counseling appropriate for use in primary care settings as well as in specialty care, clinicians have new tools to manage the range of alcohol problems across the spectrum of health care settings. By extending treatment to primary care, many people who do not currently receive specialty care may have increased access to treatment. In addition, primary care providers, by virtue of their ongoing relationship with patients, may be able to provide continuing treatment over time. Extending the spectrum of care to hazardous drinkers who may not be alcohol dependent could result in earlier intervention and reduce the consequences of excessive drinking.
PMCID: PMC3860540  PMID: 23580015
Alcohol use; abuse and dependence; harmful drinking; hazardous drinking; treatment; primary care; pharmacotherapy; medication therapy; screening; counseling; brief intervention; continuum of care
Archives of internal medicine  2007;167(7):716-721.
Screening for alcohol use in primary care settings is recommended by clinical care guidelines, but is not adhered to as strongly as screening for smoking. It has been proposed that smoking status could be used to enhance the identification of alcohol misuse in primary and other medical settings but national data are lacking.
To investigate smoking status as a clinical indicator for alcohol misuse in a national sample of US adults, following clinical care guidelines for the assessment of these behaviors.
Design, Setting, and Participants
Analyses are based on a sample of 42,565 US adults from the National Epidemiological Survey on Alcohol and Related Conditions (Wave I, 2001–2002).
Main Outcome Measures
Odds ratios (O.R.) and test characteristics (sensitivity, specificity, positive and negative predictive value [PPV, NPV], and likelihood ratio [LR] of smoking behavior (daily, occasional, former) were determined for the detection of hazardous drinking behavior and alcohol-related diagnoses, assessed by the Alcohol Use Disorder and Associated Disabilities Interview Schedule-IV.
Daily, occasional, and ex-smokers were more likely than never smokers to be hazardous drinkers (O.R.3.23 [95% CI 3.02–3.46]; O.R.5.33 [95% CI 4.70–6.04]; O.R.1.19 [95% CI 1.10–1.28], respectively). Daily and occasional smokers were more likely to meet criteria for alcohol diagnoses (O.R.3.52 [95% CI 3.19–3.90], O.R.5.39 [95% CI 4.60–6.31]; respectively). For the detection of hazardous drinking by current smoking (occasional + daily), sensitivity was 42.5%; specificity 81.9%, PPV 45.3% (vs. population rate of 26.1%), and LR+ 2.34. For the detection of alcohol diagnoses by current smoking; sensitivity was 51.4%; specificity 78.0%, PPV 17.8% (vs. population rate of 8.5%), and LR+ 2.33.
Occasional and daily smokers were at heightened risk for hazardous drinking and alcohol use diagnoses. Smoking status can be used as a clinical indicator for alcohol misuse, and as a reminder for alcohol screening in general.
PMCID: PMC2869385  PMID: 17420431
smoking; alcohol misuse; screening; clinical care guidelines
23.  Brief Intervention for Hazardous and Harmful Drinkers in the Emergency Department 
Annals of emergency medicine  2008;51(6):742-750.e2.
Study Objective
To determine efficacy of emergency practitioner performed brief intervention for hazardous/harmful drinkers in reducing alcohol consumption and negative consequences in an Emergency Department (ED) setting.
A randomized clinical trial (Project ED Health) was conducted in an urban ED from 5/2002 to 11/2003 for hazardous/harmful drinkers. Patients ≥ 18 who screened above National Institute for Alcohol Abuse and Alcoholism guidelines for “low risk” drinking or presented with an injury in the setting of alcohol ingestion were eligible. The mean number of drinks per week and binge drinking episodes over the past 30 days were collected at 6 and 12-months; negative consequences and use of treatment services at 12-months. A Brief Negotiation Interview (BNI) performed by emergency practitioners was compared to scripted discharge instructions (DI).
A total of 494 hazardous/harmful drinkers were studied. The two groups were similar with respect to baseline characteristics. In the BNI group the mean number of drinks per week at 12 months was 3.8 less than the 13.6 reported at baseline. The DI group decreased 2.6 from 12.4 at baseline. Likewise, binge drinking episodes per month decreased by 2.0 from a baseline of 6.0 in the BNI group and 1.5 from 5.4 in the DI group. For each outcome the time effect was significant and the treatment effect was not. Conclusion: Among ED patients with hazardous/harmful drinking, we did not detect a difference in efficacy between emergency practitioner-performed BNI and DI. Further studies to test the efficacy of brief intervention in the ED are needed.
PMCID: PMC2819119  PMID: 18436340
24.  Integrating Buprenorphine Treatment into Office-based Practice: a Qualitative Study 
Despite the availability and demonstrated effectiveness of office-based buprenorphine maintenance treatment (BMT), the systematic examination of physicians’ attitudes towards this new medical practice has been largely neglected.
To identify facilitators and barriers to the potential or actual implementation of BMT by office-based medical providers.
Qualitative study using individual and group semi-structured interviews.
Twenty-three practicing office-based physicians in New England.
Interviews were audiotaped, transcribed, and entered into a qualitative software program. The transcripts were thematically coded using the constant comparative method by a multidisciplinary team.
Eighty percent of the physicians were white; 55% were women. The mean number of years since graduating medical school was 14 (SD = 10). The primary areas of clinical specialization were internal medicine (50%), infectious disease (20%), and addiction medicine (15%). Physicians identified physician, patient, and logistical factors that would either facilitate or serve as a barrier to their integration of BMT into clinical practice. Physician facilitators included promoting continuity of patient care, positive perceptions of BMT, and viewing BMT as a positive alternative to methadone maintenance. Physician barriers included competing activities, lack of interest, and lack of expertise in addiction treatment. Physicians’ perceptions of patient-related barriers included concerns about confidentiality and cost, and low motivation for treatment. Perceived logistical barriers included lack of remuneration for BMT, limited ancillary support for physicians, not enough time, and a perceived low prevalence of opioid dependence in physicians’ practices.
Addressing physicians’ perceptions of facilitators and barriers to BMT is crucial to supporting the further expansion of BMT into primary care and office-based practices.
PMCID: PMC2628993  PMID: 19089500
opioid-related disorders; qualitative research; buprenorphine; physicians
25.  Cost Analysis of Clinic and Office-based Treatment of Opioid Dependence: Results with Methadone and Buprenorphine in Clinically Stable Patients 
Drug and alcohol dependence  2008;99(1-3):132-140.
The cost of providing and receiving treatment for opioid dependence can determine its adoption. To compare the cost of clinic-based methadone (MC, n=23), office-based methadone (MO, n=21), and office-based buprenorphine (BO, n=34) we performed an analysis of treatment and patient costs over 6 months of maintenance in patients who had previously been stabilized for at least one year. We performed statistical comparisons using ANOVA and chi-square tests and performed a sensitivity analysis varying cost estimates and intensity of clinical contact. The cost of providing one month of treatment per patient was $147 (MC), $220 (MO) and $336 (BO) (p<0.001). Mean monthly medication cost was $93 (MC), $86 (MO) and $257 (BO) (p<0.001). The cost to patients was $92 (MC), $63 (MO) and $38 (BO) (p=0.102). Sensitivity analyses, varying cost estimates and clinical contact, result in total monthly costs of $117 to $183 (MC), $149 to $279 (MO), $292 to $499(BO). Monthly patient costs were $84 to $133 (MC), $55 to $105 (MO) and $34 to $65 (BO). We conclude that providing clinic-based methadone is least expensive. The price of buprenorphine accounts for a major portion of the difference in costs. For patients, office-based treatment may be less expensive.
PMCID: PMC2646001  PMID: 18804923
Costs and cost analysis; opioid-related disorders; methadone; buprenorphine

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