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1.  Disseminating Organizational Screening and Brief Intervention Services (DO-SBIS) for Alcohol at Trauma Centers Study Design 
General hospital psychiatry  2012;35(2):174-180.
Objective
In 2005 the American College of Surgeons passed a mandate requiring that Level I trauma centers have a mechanism to identify patients who are problem drinkers and have the capacity to provide an intervention for patients who screen positive. The aim of the Disseminating Organizational Screening and Brief Intervention Services (DO-SBIS) cluster randomized trial is to test a multilevel intervention targeting the implementation of high quality alcohol screening and brief intervention (SBI) services at trauma centers.
Method
Twenty sites selected from all US Level I trauma centers were randomized to participate in the trial. Intervention site providers receive a combination of workshop training in evidence-based motivational interviewing (MI) interventions and organizational development activities prior to conducting trauma center-based alcohol SBI with blood alcohol positive injured patients. Control sites implement care as usual. Provider MI skills, patient alcohol consumption, and organizational acceptance of SBI implementation outcomes are assessed.
Results
The investigation has successfully recruited provider, patient, and trauma center staff samples into the study and outcomes are being followed longitudinally.
Conclusion
When completed, the DO-SBIS trial will inform future American College of Surgeons’ policy targeting the sustained integration of high quality alcohol SBI at trauma centers nationwide.
doi:10.1016/j.genhosppsych.2012.11.012
PMCID: PMC3594343  PMID: 23273831
Acute care medical trauma centers; Injury; Alcohol; Screening and brief intervention; American College of Surgeons
2.  Stimulant Abuser Groups to Engage in 12-Step (STAGE-12): A Multisite Trial in the NIDA Clinical Trials Network 
Aims
The study evaluated the effectiveness of an 8-week combined group plus individual 12-step facilitative intervention on stimulant drug use and 12-step meeting attendance and service.
Design
Multisite randomized controlled trial, with assessments at baseline, mid-treatment, end of treatment, and 3- and 6-month post-randomization follow-ups (FU).
Setting
Intensive outpatient substance treatment programs.
Participants
Individuals with stimulant use disorders (n = 471) randomly assigned to treatment as usual (TAU) or TAU into which the STAGE-12 intervention was integrated.
Measurements
Urinalysis and self-reports of substance use and 12-step attendance and activities.
Intervention
Group sessions focused on increasing acceptance of 12-step principles; individual sessions incorporated an intensive referral procedure connecting participants to 12-step volunteers.
Findings
Compared to TAU, STAGE-12 participants had significantly greater odds of self-reported stimulant abstinence during the active 8-week treatment phase; however, among those who had not achieved abstinence during this period, STAGE-12 participants had more days of use. STAGE-12 participants had lower ASI Drug Composite scores at and a significant reduction from baseline to the 3-month FU, attended 12-step meetings on a greater number of days during the early phase of active treatment, engaged in more other types of 12-step activities throughout the active treatment phase and the entire FU period, and had more days of self-reported service at meetings from mid-treatment through the 6-month FU.
Conclusions
The present findings are mixed with respect to the impact of integrating the STAGE-12 intervention into intensive outpatient drug treatment compared to TAU on stimulant drug use. However, the results more clearly indicate that individuals in STAGE-12 had higher rates of 12-step meeting attendance and were engaged in more related activities throughout both the active treatment phase and the entire 6-month follow-up period than did those in TAU.
doi:10.1016/j.jsat.2012.04.004
PMCID: PMC3434261  PMID: 22657748
3.  Risk for Prescription Opioid Misuse among Patients with a History of Substance Use Disorder 
Drug and alcohol dependence  2012;127(1-3):193-199.
BACKGROUND
History of substance use disorder (SUD) is associated with risk for prescription opioid misuse in chronic pain patients; however, little data are available regarding risk for prescription opioid misuse within the subgroup of patients with SUD histories.
METHODS
Participants with chronic pain, histories of SUD, and current opioid prescriptions were recruited from a single VA Medical Center. Participants (n=80) completed measures of risk for prescription opioid misuse, pain severity, pain-related interference, pain catastrophizing, attitudes about managing pain, emotional functioning, and substance abuse.
RESULTS
Participants were divided into three groups based on risk for prescription opioid misuse, as assessed by the Pain Medication Questionnaire (PMQ). Participants in the High-PMQ group reported more pain severity, interference, catastrophizing, depressive symptoms, and lowest self-efficacy for managing pain, relative to the Low-PMQ group; the High-PMQ group and Moderate-PMQ group differed on measures of pain severity, catastrophizing, and psychiatric symptoms (all p-values <0.05). The High-PMQ group had the highest rates of current SUD (32% versus 20% and 0, p=0.009). A regression analysis evaluated factors associated with PMQ scores: pain catastrophizing was the only variable significantly associated with risk for prescription opioid misuse.
CONCLUSIONS
Among patients with SUD histories, those with higher risk for prescription opioid misuse reported more pain and impairment, symptoms of depression, and were more likely to have current SUD, relative to patients with lower risk for prescription opioid misuse. In adjusted analyses, pain catastrophizing was significantly associated with risk for prescription opioid misuse, but current SUD status was not a significant predictor.
doi:10.1016/j.drugalcdep.2012.06.032
PMCID: PMC3484237  PMID: 22818513
Prescription opioid misuse; Chronic pain; Substance use disorder; Aberrant medication-related behaviors; Quality of life
4.  Substance Use and PTSD Symptoms in Trauma Center Patients Receiving Mandated Alcohol SBI 
In an effort to integrate substance abuse treatment at trauma centers, the American College of Surgeons has mandated alcohol screening and brief intervention (SBI). Few investigations have assessed trauma center inpatients for comorbidities that may impact the effectiveness of SBI that exclusively focuses on alcohol. Randomly selected SBI eligible acute care medical inpatients (N=878) were evaluated for alcohol, illegal drugs, and symptoms consistent with a diagnosis of posttraumatic stress disorder (PTSD) using electronic medical record, toxicology, and self-report assessments; 79% of all patients had one or more alcohol, illegal drug, or PTSD symptom comorbidity. Over 70% of patients receiving alcohol SBI (n=166) demonstrated one or more illegal drug or PTSD symptom comorbidity. A majority of trauma center inpatients have comorbidities that may impact the effectiveness of mandated alcohol SBI. Investigations that realistically capture, account for, and intervene upon these common comorbid presentations are required to inform the iterative development of College policy targeting integrated substance abuse treatment at trauma centers.
doi:10.1016/j.jsat.2012.08.009
PMCID: PMC3528356  PMID: 22999379
5.  12-Step Interventions and Mutual Support Programs for Substance Use Disorders: An Overview 
Social work in public health  2013;28(0):313-332.
Social workers and other behavioral health professionals are likely to encounter individuals with substance use disorders in a variety of practice settings outside of specialty treatment. 12-Step mutual support programs represent readily available, no cost community-based resources for such individuals; however, practitioners are often unfamiliar with such programs. The present article provides a brief overview of 12-Step programs, the positive substance use and psychosocial outcomes associated with active 12-Step involvement, and approaches ranging from ones that can be utilized by social workers in any practice setting to those developed for specialty treatment programs to facilitate engagement in 12-Step meetings and recovery activities. The goal is to familiarize social workers with 12-Step approaches so that they are better able to make informed referrals that match clients to mutual support groups that best meet the individual’s needs and maximize the likelihood of engagement and positive outcomes.
doi:10.1080/19371918.2013.774663
PMCID: PMC3753023  PMID: 23731422
12-Step; mutual support; self-help; recovery activities
6.  Substance Use, Treatment Admissions, and Recovery Trends in Diverse Washington State Tribal Communities 
Background
Qualitative and quantitative data and participatory research approaches might be most valid and effective for assessing substance use/abuse and related trends in American Indian and Alaska Native (AIAN) communities.
Method
29 federally recognized AIAN Tribes in Washington (WA) State were invited to participate in Health Directors interviews and State treatment admissions data analyses. Ten Tribal Health Directors (or designees) from across WA participated in 30–60 minute qualitative interviews. State treatment admissions data from 2002–2008 were analyzed for those who identified with one of 11 participating AIAN communities to explore admission rates by primary drug compared to non-AIANs. Those who entered treatment and belonged to one of the 11 participating tribes (n=4,851) represented 16% of admissions for those who reported a tribal affiliation.
Results
Interviewees reported that prescription drugs, alcohol and marijuana are primary community concerns, each presenting similar and distinct challenges. Additionally, community health is tied to access to resources, services, and culturally appropriate and effective interventions. Treatment data results were consistent with interviewee reported substance use/abuse trends, with alcohol as the primary drug for 56% of AIAN adults compared to 46% of non-AIAN, and other opiates as second most common for AIAN adults in 2008 with 15% of admissions.
Limitations
Findings are limited to those tribal communities/community members who agreed to participate.
Conclusion
Analyses suggest that some diverse AIAN communities in WA State share similar substance use/abuse, treatment, and recovery trends and continuing needs.
Scientific Significance
Appropriate and effective research with AIAN communities requires respectful and flexible approaches.
doi:10.3109/00952990.2012.694533
PMCID: PMC3736985  PMID: 22931087
substance use; treatment; recovery; American Indian; Washington
7.  Mindful Awareness in Body-oriented Therapy as an Adjunct to Women’s Substance Use Disorder Treatment: A Pilot Feasibility Study 
This study examined Mindful Awareness in Body-oriented Therapy (MABT) feasibility as a novel adjunct to women’s substance use disorder (SUD) treatment. An individual therapy, MABT combines manual and mind-body approaches to develop interoception and self-care tools for emotion regulation. A 2-group RCT repeated measures design was used, comparing MABT to treatment-as-usual (TAU) on relapse to substance use and related health outcomes. Sixty-one women were screened for eligibility and 46 enrolled. Participants randomized to MABT received 8 weekly MABT sessions. Results showed moderate to large effects, including significantly fewer days on substance use, the primary outcome, for MABT compared to TAU at post-test. Secondary outcomes showed improved eating disorder symptoms, depression, anxiety, dissociation, perceived stress, physical symptom frequency, and bodily dissociation for MABT compared to TAU at 9 month follow-up. In conclusion, it is feasible to implement MABT in women’s SUD treatment and results suggest that MABT is worthy of further efficacy testing.
doi:10.1016/j.jsat.2011.09.016
PMCID: PMC3290748  PMID: 22119181
Addiction; Substance Use Disorder Treatment; Women; Body-Mind Intervention; Manual Therapy; Mindfulness; Interoception
8.  Drink refusal training as part of a combined behavioral intervention: Effectiveness and mechanisms of change 
Objective
Many trials have demonstrated the effectiveness of cognitive behavioral interventions for alcohol dependence, yet few studies have examined why particular treatments are effective. This study was designed to evaluate whether drink refusal training was an effective component of a combined behavioral intervention (CBI) and whether change in self-efficacy was a mechanism of change following drink refusal training for individuals with alcohol dependence.
Method
The current study is a secondary analysis of data from the COMBINE study, a randomized clinical trial that combined pharmacotherapy with behavioral intervention in the treatment of alcohol dependence. The goal of the current study was to examine whether a drink refusal skills training module, administered as part of a 16-week CBI (n=776; 31% female, 23% non-White, average age=44) predicted changes in drinking frequency and self-efficacy during and following the CBI, and whether changes in self-efficacy following drink refusal training predicted changes in drinking frequency up to one year following treatment.
Results
Participants (n=302) who received drink refusal skills training had significantly fewer drinking days during treatment (d=0.50) and up to one year following treatment (d=0.23). In addition the effect of the drink refusal skills training module on drinking outcomes following treatment was significantly mediated by changes in self-efficacy, even after controlling for changes in drinking outcomes during treatment (proportion mediated = 0.47).
Conclusions
Drink refusal training is an effective component of CBI and some of the effectiveness may be attributed to changes in client self-efficacy.
doi:10.1037/a0026996
PMCID: PMC3349797  PMID: 22289131
self-efficacy; drink refusal skills training; drinking outcomes; alcohol dependence; mechanisms of change
9.  Implementation and Acceptability of Mindful Awareness in Body-Oriented Therapy in Women's Substance Use Disorder Treatment 
Abstract
Objectives
The purpose of this study was to examine the implementation and acceptability of Mindful Awareness in Body-oriented Therapy (MABT), a novel adjunctive approach to substance use disorder (SUD) treatment. The primary aims of the study were to examine implementation of MABT as an adjunct to addiction treatment, and MABT acceptability to study participants and treatment staff.
Methods
MABT was delivered to participants randomly assigned to the intervention in a larger ongoing trial. This study focuses only on the implementation and acceptability of the intervention, as outcomes are not yet available. MABT was delivered once weekly for 8 weeks (1.5-hour sessions) and spanned inpatient and outpatient programs at a women-only treatment facility. Descriptive statistics were used to examine participant recruitment and retention to the intervention. To measure MABT acceptability, survey and written questionnaires were administered; analysis involved descriptive statistics and content analysis using Atlas.ti software.
Results
Thirty-one (31) of the women enrolled in the study were randomized to MABT. Eighteen (18) participants completed 75%–100% of the MABT sessions. Intervention implementation required flexibility on the part of both the researchers and the clinic staff, and minor changes were made to successfully implement MABT as an adjunct to usual care. MABT was perceived to increase emotional awareness and provide new tools to cope with stress, and to positively influence SUD treatment by facilitating emotion regulation.
Conclusions
It was feasible to implement MABT and to recruit and retain women to MABT in women's chemical-dependency treatment. MABT acceptability and perceived benefit was high.
doi:10.1089/acm.2011.0126
PMCID: PMC3353814  PMID: 22524991
10.  Baseline Trajectories of Heavy Drinking and their Effects on Post-Randomization Drinking in the COMBINE Study: Empirically Derived Predictors of Drinking Outcomes During Treatment 
Alcohol (Fayetteville, N.y.)  2011;46(2):121-131.
The COMBINE Study sought to answer questions about the benefits of combining behavioral and pharmacological interventions (naltrexone and acamprosate) in alcohol-dependent patients. Our goals were to identify trajectories of heavy drinking prior to randomization in COMBINE, to characterize subjects in these trajectories, and to assess whether pre-randomization trajectories predict drinking outcomes. We analyzed daily indicators of heavy drinking in 90 days prior to randomization using a trajectory-based approach. Each subject was assigned to the most-likely pre-randomization heavy drinking trajectory, and the baseline characteristics of participants in the baseline trajectories were compared. Main and interactive effects of these trajectories and treatment factors (acamprosate, naltrexone or CBI) on summary drinking measures during active treatment (16 weeks) were assessed. We identified five trajectories of heavy drinking pre-randomization: “T1: frequent heavy drinkers”, “T2: very frequent heavy drinkers”, “T3: nearly daily heavy drinkers”, “T4: daily heavy drinkers” and “T5: daily heavy drinkers stopping early” prior to randomization. Trajectory membership was significantly associated with all drinking outcomes. Subjects in “T5: daily heavy drinkers stopping early” had comparable drinking outcomes to the subjects in “T1: frequent heavy drinkers” while the remaining trajectories were associated with significantly worse outcomes. Baseline trajectory did not interact significantly with treatment condition. These exploratory analyses confirmed the hypothesis that baseline trajectories predict post-randomization drinking outcomes. Interestingly, “T5: daily heavy drinkers stopping early” had outcomes that were comparable to the least severe baseline trajectory “T1: frequent heavy drinkers” and baseline trajectories of heavy drinking did not moderate treatment effects.
doi:10.1016/j.alcohol.2011.08.008
PMCID: PMC3266454  PMID: 21925828
trajectory-based analysis; clinical trial; baseline predictors; naltrexone; acamprosate; combined behavioral intervention
11.  A Multi-Level Approach to Predicting Community Addiction Treatment Attitudes About Contingency Management 
Adoption of contingency management (CM) by the addiction treatment community is limited to date despite much evidence for its efficacy. This study examined systemic and idiographic staff predictors of CM adoption attitudes via archival data collected from treatment organizations affiliated with the National Drug Abuse Treatment Clinical Trials Network. Multilevel modeling analyses evaluated potential predictors from organizational, treatment unit, and workforce surveys. Among these were individual and shared perceptions of staff concerning aspects of their clinic culture and climate. Modeling analyses identified three systemic predictors (clinic provision of opiate agonist services, national accreditation, lesser shared perception of workplace stress) and five idiographic predictors (staff with a graduate degree, longer service tenure, managerial position, e-communication facility, and openness to change in clinical procedures). Findings are discussed as they relate to extant literature on CM attitudes and established implementation science constructs, and their practical implications are discussed.
doi:10.1016/j.jsat.2011.10.012
PMCID: PMC3268877  PMID: 22138199
12.  Primary outcome indices in illicit drug dependence treatment research: systematic approach to selection and measurement of drug use end-points in clinical trials 
Addiction (Abingdon, England)  2011;107(4):694-708.
Aims
Clinical trials test the safety and efficacy of behavioral and pharmacological interventions in drug-dependent individuals. However, there is no consensus about the most appropriate outcome(s) to consider in determining treatment efficacy or on the most appropriate methods for assessing selected outcome(s). We summarize the discussion and recommendations of treatment and research experts, convened by the US National Institute on Drug Abuse, to select appropriate primary outcomes for drug dependence treatment clinical trials, and in particular the feasibility of selecting a common outcome to be included in all or most trials.
Methods
A brief history of outcomes employed in prior drug dependence treatment research, incorporating perspectives from tobacco and alcohol research, is included. The relative merits and limitations of focusing on drug-taking behavior, as measured by self-report and qualitative or quantitative biological markers, are evaluated.
Results
Drug-taking behavior, measured ideally by a combination of self-report and biological indicators, is seen as the most appropriate proximal primary outcome in drug dependence treatment clinical trials.
Conclusions
We conclude that the most appropriate outcome will vary as a function of salient variables inherent in the clinical trial, such as the type of intervention, its target, treatment goals (e.g. abstinence or reduction of use) and the perspective being taken (e.g. researcher, clinical program, patient, society). It is recommended that a decision process, based on such trial variables, be developed to guide the selection of primary and secondary outcomes as well as the methods to assess them.
doi:10.1111/j.1360-0443.2011.03473.x
PMCID: PMC3537825  PMID: 21781202
Clinical trials; drug dependence; end-points; primary outcome; self-report; toxicology; treatment research
13.  Identifying Community Needs and Resources in a Native Community: A Research Partnership in the Pacific Northwest 
Indigenous communities have engaged in needs and resources assessments for thousands of years. By blending CBPR/TPR approaches with community-driven assets and needs assessments, academic and community based researchers can work together to better understand and identify community strengths as well as issues of concern in Native communities. This best practice approach can set research agendas that are relevant to Native communities and result in interventions and health promotion programs that are respectful of Tribal sovereignty and that incorporate unique traditions and strengths of Native communities. A successful research partnership to develop and implement a needs and resources assessment using CBPR/TPR approaches is presented using a case study that can be used as a model for other research partnerships.
doi:10.1007/s11469-009-9233-1
PMCID: PMC3487410  PMID: 23123765
American Indian and Alaska Native; CBPR; TPR; Needs and resources assessment; Substance abuse; Cultural identity
14.  Validation of a Nine-Dimensional Measure of Drinking Motives for Use in Clinical Applications: The Desired Effects of Drinking Scale 
Addictive behaviors  2011;36(11):1052-1060.
The Desired Effects of Drinking (DEOD) is a 36-item, 9-subscale, self-report measure assessing reasons for drinking, concerning three general motives for alcohol use: Coping, Social, and Enhancement. These subscales include Negative Feelings, Self-esteem, Relief, Positive Feelings, Social Facilitation, Assertion, Drug Effects, Sexual Enhancement, and Mental effects. As part of the COMBINE study, scores from the nine DEOD subscales, along with additional information about alcohol consumption and consequences, were incorporated into personalized client feedback as part of a motivational enhancement intervention and as a guide for the development of a plan for treatment and change. With responses from a clinical sample of 572 individuals seeking alcohol treatment, the 9-subscale structure of the instrument was substantiated through a second-order confirmatory factor analysis, revealing moderately large to large factor loadings and good indices of model fit. A third-order factor analysis indicated these nine subscales adequately represented the three drinking motives. It is suggested these three general motives for alcohol use, which may be more distinctly delineated into the nine dimensions reflected in the DEOD structure, can be used clinically to help plan appropriate interventions and facilitate behavior change.
doi:10.1016/j.addbeh.2011.06.012
PMCID: PMC3153563  PMID: 21782346
drinking motives; confirmatory factor analysis; concurrent validity; predictive validity
15.  Research Partnerships between Academic Institutions and American Indian and Alaska Native Tribes and Organizations: Effective Strategies and Lessons Learned in a Multi-Site CTN Study 
Community Based and Tribally Based Participatory Research (CBPR/TPR) are approaches that can be successful for developing ethical and effective research partnerships between academic institutions and Tribes and Native organizations. The NIDA Clinical Trials Network funded a multi-site, exploratory study using CBPR/TPR to begin to better understand substance abuse issues of concern to some Tribes and Native organizations as well as strengths and resources that exist in these communities to address these concerns. Each of the five sites is briefly described and a summary of the common themes for developing these collaborative research efforts is provided.
doi:10.3109/00952990.2011.596976
PMCID: PMC3465683  PMID: 21854275
American Indian and Alaska Native; CBPR/TPR; substance abuse; strengths based research
16.  Site selection in community-based clinical trials for substance use disorders: Strategies for effective site selection 
Background
The importance of conducting substance use disorder treatment research in real-world settings is now well recognized. While this approach to clinical trials research offers a variety of benefits, challenges also arise. Selecting high quality sites to participate is critical to recruitment, retention, and overall trial performance when conducting multi-site, community-based clinical trials of treatments for substance use disorders.
Objectives
Over the past 10 years, the NIDA-sponsored National Drug Abuse Treatment Clinical Trials Network (CTN) has strived to conduct high-quality, well-managed clinical trials. This includes developing methods for site selection to be used by investigators conducting CTN trials.
Results
Issues relevant to site selection include the clinical trial design, availability of appropriate clinical population, and organizational attributes of potential clinical research sites. Site selection strategies include reviewing regional epidemiologic data, collecting standard site selection surveys, evaluating clinic data on existing patient populations, and site selection interviews and visits.
Conclusions
This paper describes considerations for selecting research sites and identifies specific strategies to employ when selecting community-based sites for participation in clinical trials.
doi:10.3109/00952990.2011.596975
PMCID: PMC3160724  PMID: 21854283
17.  DESIGN OF NIDA CTN PROTOCOL 0047: SCREENING, MOTIVATIONAL ASSESSMENT, REFERRAL, AND TREATMENT IN EMERGENCY DEPARTMENTS (SMART-ED) 
Background
Medical settings such as emergency departments (EDs) present an opportunity to identify and provide services for individuals with substance use problems who might otherwise never receive any form of assessment, referral, or intervention. Although Screening, Brief Intervention, and Referral to Treatment (SBIRT) models have been extensively studied and are considered effective for individuals with alcohol problems presenting in emergency departments and other medical settings, the efficacy of such interventions has not been established for drug users presenting in EDs.
Objectives
This paper describes the design of a NIDA Clinical Trials Network protocol testing the efficacy of an SBIRT model in medical EDs, highlighting considerations that that are pertinent to the design of other studies targeting substance use behaviors in medical treatment settings.
Methods
The protocol is described, and critical design decisions are discussed.
Results
Design challenges included defining treatment conditions, study population, and site characteristics; developing the screening process; choosing the primary outcome; balancing brevity and comprehensiveness of assessment; and selecting the strategy for statistical analysis.
Conclusion
Many of the issues arising in the design of this study will be relevant to future studies of interventions for addictions in medical settings.
Scientific Significance
Optimal trial design is critical to determining how best to integrate substance abuse interventions into medical care.
doi:10.3109/00952990.2011.596971
PMCID: PMC3168577  PMID: 21854285
18.  How Practice and Science Are Balanced and Blended in the NIDA Clinical Trials Network: The Bidirectional Process in the Development of the STAGE-12 Protocol as an Example 
Background
Bidirectional, collaborative partnerships between academic researchers and practitioners have been a fundamental vehicle to achieve the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) goal of improving outcomes of community-based drug treatment. These partnerships blend clinical perspectives of practitioners and methodological expertise of researchers working together to address clinically meaningful issues through randomized clinical trials conducted in community treatment settings.
Objectives
Bidirectionality is a guiding principle of the CTN, but its operationlization at the practical level in protocol development and implementation has not been articulated. This descriptive article presents the development of one protocol as an example and model of this bidirectional, collaborative, iterative partnership between researchers and practitioners.
Methods
This article illuminates several specific issues encountered while developing STAGE-12, a behavioral intervention to facilitate 12-step mutual support group involvement, as well as the rationale for decisions taken to resolve each.
Results
The STAGE-12 protocol was successfully developed through a series of decisions taking into account both design factors and clinical practice needs and realities, thus maintaining a balance between methodological rigor and generalizability.
Conclusion
The review demonstrates the process by which research and practice have been blended in protocol development, exemplifying the underlying principle of bidirectionality, a key element in the success of the NIDA CTN.
Scientific Significance
Bidirectional partnerships as derived in the CTN, employing a hybrid model of efficacy-effectiveness research, are capable of designing and implementing protocols that are both methodologically rigorous and clinically meaningful, thus increasing likelihood of adoption and eventual improvement in public health.
doi:10.3109/00952990.2011.596970
PMCID: PMC3260794  PMID: 21854284
bidirectionality; research; clinical practice; internal validity; external validity; clinical trials network; protocol development
21.  Self-Efficacy Change as a Mediator of Associations between Therapeutic Bond and One-Year Outcomes in Treatments for Alcohol Dependence 
Empirically-supported treatments for alcohol dependence exist, yet understanding of influences contributing to the intended behavior change is limited. The current study, a secondary analysis of the recent multi-site COMBINE trial (The COMBINE Study Research Group, 2003), tested a mediational model wherein change in client self-efficacy for abstinence was examined as a potential mediator of associations between client-report of the therapeutic bond and one-year outcomes of drinking frequency, drinking consequences, and psychiatric functioning. For analyses, the 1383 COMBINE trial participants were grouped as follows: 1) those receiving study medications (Naltrexone, Acamprosate, Naltrexone + Acamprosate, Placebo) and enrolled in medication management (MM) only (n=607), 2) those receiving study medications/MM and also enrolled in a combination behavioral intervention (CBI) as well (n=619), and 3) those enrolled in CBI only (n=157). Mediation analyses using the product-of-coefficients approach indicated self-efficacy change during treatment significantly mediated associations between the therapeutic bond with the CBI therapist and each of the three one-year outcomes among those exclusively receiving CBI, but failed to do so among those receiving pills/MM (with or without CBI). Effect sizes were small, but indicated that variance in bond-outcome associations was partially mediated by self-efficacy change for trial participants. Findings advance understanding of proximal client change processes during delivery of treatments for alcohol dependence.
doi:10.1037/a0022869
PMCID: PMC3236109  PMID: 21443293
alcohol treatment; therapeutic bond; self-efficacy
22.  Baseline Trajectories of Drinking Moderate Acamprosate and Naltrexone Effects in the COMBINE study 
Background
The COMBINE Study evaluated the effects of acamprosate, naltrexone and the Combined Behavioral Intervention (CBI). In secondary analyses, our goals were to identify trajectories of any drinking prior to randomization, to characterize subjects in these trajectories, and to assess whether pre-randomization trajectories predict drinking outcomes and moderate treatment response.
Methods
We analyzed daily indicators of any drinking in 90 days prior to randomization using a trajectory-based approach. General linear models and generalized logistic regression assessed main and interactive effects of pre-randomization drinking trajectories and treatment on summary drinking measures during active treatment.
Results
We identified five trajectories of any drinking prior to randomization: “T1: frequent drinkers”, “T2: very frequent drinkers”, “T3: nearly daily drinkers”, “T4: consistent daily drinkers” and “T5: daily drinkers stopping early”. During treatment, “T3: nearly daily drinkers” and “T4: consistent daily drinkers” had significantly worse drinking outcomes than “T1: frequent drinkers” while “T5: daily drinkers stopping early” had comparable drinking outcomes to “T1: frequent drinkers”. Acamprosate significantly increased the chance of abstinence from heavy drinking for the “T2: very frequent drinking” trajectory but decreased the chance of abstinence from heavy drinking for “T5: daily drinkers stopping early”. Naltrexone differentially improved rates of continuous abstinence for very frequent drinkers.
Conclusions
Acamprosate benefited very frequent drinkers and contrary to expectations was associated with poorer response compared to placebo for consistent daily drinkers who had longer durations of pretreatment abstinence (e.g., ≥ 14 days). Baseline drinking trajectories also moderated naltrexone effects. These findings may help clinicians identify patients for whom acamprosate and naltrexone may be most beneficial.
doi:10.1111/j.1530-0277.2010.01369.x
PMCID: PMC3062945  PMID: 21143249
naltrexone; acamprosate; clinical trial; latent class; trajectory-based analysis
23.  Moderating Effects of a Craving Intervention on the Relation between Negative Mood and Heavy Drinking following Treatment for Alcohol Dependence 
Objective
Negative affect is a significant predictor of alcohol relapse, and the relation between negative affect and drinking has been shown to be strongly mediated by alcohol craving. Thus, targeting craving during treatment could potentially attenuate the relation between negative affect and drinking.
Method
The current study is a secondary analysis of data from the COMBINE study, a randomized clinical trial that combined pharmacotherapy with behavioral intervention in the treatment of alcohol dependence. The goal of the current study was to examine whether a treatment module that targeted craving would predict changes in negative mood during the 16-week Combined Behavioral Intervention (CBI; n=776) and the relation between changes in mood, craving, and changes in heavy drinking during treatment and one year posttreatment.
Results
Changes in negative mood were significantly associated with changes in heavy drinking during treatment (f2=0.78). Participants (n=432) who received the craving module had significantly fewer heavy drinking days during treatment (d = 0.31) and receiving the module moderated the relation between negative mood and heavy drinking during treatment (f2=0.92) and one year posttreatment (f2=0.03). Moderating effects of the craving module were mediated by changes in craving during treatment. Within subject analyses indicated significant pre- to post-module reductions in negative mood. Additionally, post-module craving significantly mediated the association between negative mood and heavy drinking during treatment and posttreatment.
Conclusions
The craving module of CBI may weaken the relation between negative affect and heavy drinking by fostering greater decreases in craving during treatment.
doi:10.1037/a0022282
PMCID: PMC3157314  PMID: 21261434
craving; negative mood; heavy drinking; urge surfing; behavioral intervention

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