Our study found that patient-centered home-based inductions were feasible and preferred by the vast majority of participants. In addition, taking into account the limitations of our observational cohort study design, patient-centered home-based inductions were equally successful in reducing opioid use and more successful in reducing any drug use than standard-of-care office-based inductions. The greatest reduction in opioid use and any drug use occurred between baseline and 1 month of follow-up, and these reductions endured through 6 months.
To our knowledge, our study is the first to demonstrate better buprenorphine treatment outcomes among patients receiving unobserved home-based inductions, when compared to those receiving observed office-based inductions. We are aware of three other studies that have examined the emerging clinical practice of unobserved inductions occurring outside of medical offices (Lee, J. D., Grossman, E., DiRocco, D., & Gourevitch, M. N., 2009
; Alford, D. P. et al., 2007
). However, one study by Lee and colleagues examined treatment outcomes of a single group of patients with home-based inductions and had no comparison group (Lee, J. D., Grossman, E., DiRocco, D., & Gourevitch, M. N., 2009
). Another study by Alford and colleagues had a substantially different comparison group, as that study’s main goal was to compare buprenorphine treatment outcomes between housed to homeless patients, in which housed patients received phone-guided home-based inductions, and homeless patients received observed office-based inductions (Alford, D. P. et al., 2007
). In that study, treatment outcomes were similar between the two groups. The final study, in which we retrospectively compared patients who had home-based versus office-based inductions, we found similar treatment retention rates (Sohler, N. L. et al., 2010
). When examining drug use among patients who received unobserved home-based inductions, these studies are consistent with our study’s findings. At 3–6 months, opioid use was reported in approximately 10–30% of patients in these studies (Lee, J. D., Grossman, E., DiRocco, D., & Gourevitch, M. N., 2009
; Alford, D. P. et al., 2007
), while in our study, at 6 months, opioid use was reported in 24% of participants. Thus, to date, all published studies examining unobserved home-based inductions consistently demonstrate positive buprenorphine treatment outcomes with this induction strategy. Our study advances existing knowledge by further demonstrating that our patient-centered home-based induction strategy had better treatment outcomes than a standard-of-care office-based induction strategy.
Because drug addiction is a chronic medical condition (O'Brien, C. P. & McLellan, A. T., 1996
; McLellan, A. T., Lewis, D. C., O'Brien, C. P., & Kleber, H. D., 2000
), we used an established model of chronic disease management—the Chronic Care Model (CCM)—to guide our patient-centered home-based buprenorphine induction strategy. The CCM emphasizes the central role of patients, challenges the traditional notion that physicians are the sole people directing care, and allows patients to use their expertise with addiction (Wagner, E. H. et al., 2001
; Wagner, E. H., 1998
). We developed patient-centered home-based inductions to focus on one component of the CCM—improving self-management support. We believe that activating patients to engage in self-management of their addiction during buprenorphine induction set the stage for improved long-term outcomes.
Although we did not specifically explore why participants with patient-centered home-based inductions (versus standard-of-care office-based inductions) had significantly greater reductions in any drug use and not in opioid use, we believe that patients’ self-management of their opioid addiction affected their self-management of other drug use as well. This is supported by the Figures, which demonstrate that all participants had significant reductions in opioid use and any drug use within the first month after induction. However, when all participants received less intensive treatment during the maintenance phase (e.g. 3 months after induction), and when self-management strategies are needed and important, further reductions in opioid use and any drug use occurred only in those with patient-centered home-based inductions, in which self-management was emphasized. For example, during the maintenance phase, if participants experienced drug cravings, those who practiced self-management skills during patient-centered home-based inductions may have been better equipped to manage their cravings than others who did not practice self management skills and had standard-of-care office-based inductions. Because buprenorphine effectively treats opioid addiction, it is possible that with our small sample size, we could not detect significant differences in opioid use between induction strategies. However, because buprenorphine is not effective in reducing drugs other than opioids, it is likely that self-management, which was promoted in and practiced by those who had patient-centered home-based inductions, was key in reducing other drug use. Further exploration of innovative buprenorphine treatment strategies based on established models of chronic care disease management are needed.
The induction phase is challenging and important. Many treatment failures occur during induction, and those who remain in treatment past induction are likely to remain in treatment long-term (Lee, J. D., Grossman, E., DiRocco, D., & Gourevitch, M. N., 2009
; Stein, M. D., Cioe, P., & Friedmann, P. D., 2005
; Whitley, S. D. et al., 2009). Our data are consistent with prior studies, demonstrating that significant reduction in opioid use occurs in the first month of treatment and is sustained through six months. Our data reinforce the importance of the induction, which is key in the early reduction of opioid use. Because national guidelines recommend an office-based induction process that requires precise timing, observed dosing, and multiple assessments, orchestrating inductions can be difficult (Center for Substance Abuse Treatment., 2007
). Given the importance and challenges associated with buprenorphine inductions, physicians are beginning to offer new buprenorphine induction strategies that are unobserved and occur outside of medical settings (Walley, A. Y. et al., 2008). In addition, when given the choice of induction strategies, nearly all our participants chose patient-centered home-based inductions. Although our current study did not examine adverse effects associated with each induction strategy, in our previous studies we reported similar rates of complicated inductions (e.g., inductions with precipitated or protracted opioid withdrawal) in patients who received patient-centered home-based inductions and standard-of-care office-based inductions (Whitley, S. D. et al., 2010; Sohler, N. L. et al., 2010
). Because physicians and patients are interested in home-based inductions, and thoroughly described theory-based home-based induction protocols are lacking, development of evidence-based induction strategies that allow for unobserved inductions to occur outside of medical offices is urgently needed.
4.1 Study Limitations
Our study has several limitations. Participants were not assigned an induction strategy, rather, they chose one; thus, selection bias was possible. Due to changes in our study inclusion criteria, those with standard-of-care office-based inductions were more likely to be HIV-positive than those with patient-centered home-based inductions. To explore the association between HIV status and buprenorphine treatment outcomes, we conducted additional exploratory analyses among participants with patient-centered home-based inductions. We found no significant difference in opioid use (AOR=1.00) or any drug use (AOR=1.04) between participants who were HIV-positive versus -negative. In addition to this difference in HIV status between the two induction groups, unmeasured factors could also have biased our finding. Because patient-centered home-based inductions were available during the latter half of our study, it is possible that temporal factors such as physician or participant experience with buprenorphine may have affected outcomes. However, both induction strategies used standardized clinical protocols, thereby reducing the potential effect that either patient or provider experience may have had on outcomes
Additional limitations included our small sample size, which limited our ability to detect potential differences between the two groups. Because urine toxicology tests were collected for clinical care, and not research, our study relied on self-reported drug use, which may not accurately portray ongoing drug use and is subject to recall bias. Finally, because our study was limited to one clinical site, our findings may not be generalizable to other populations.
Our study, which compared two different buprenorphine induction strategies, found that patient-centered home-based inductions were feasible and preferred by the vast majority of participants. In addition, taking into account the limitations of our observational cohort study design, participants with patient-centered home-based inductions (versus standard-of-care office-based inductions) had similar reductions in opioid use and greater reductions in any drug use over six months. As innovative treatment strategies related to buprenorphine inductions are emerging, it is essential that they be based on established theories or models and well-studied to optimize treatment outcomes for opioid addiction.