Abstract
Opioid use disorder (OUD) can encompass a number of behavioral, psychological, physiological, and interpersonal symptoms which collectively impair one’s functioning to different degrees. Of all the personal and societal problems associated with OUD, the most destructive and absolute is death. Given the caustic effects of OUD on quality of life and mortality, evidence-based pharmacotherapy and psychosocial interventions are necessary. It is the collective potential for buprenorphine to increase safety and concurrent cognitive-behavioral group therapy (CBGT) to address substance use triggers as well as comorbid psychiatric conditions, which makes this combination particularly promising for RCT of effectiveness. The purposes of this article are to (1) identify specific ethical issues which may hinder community partners from collaborating with clinical trialist wishing to conduct CBGT buprenorphine efficacy-effectiveness trials at their agency and (2) provide some basic guidelines (Yale CARE strategies) and methods for addressing these community partner ethical concerns. The purpose of the manuscript is to facilitate university and substance use/mental health center community collaborations that will result in ethical clinical trial methodology and findings that meaningfully translate to efficacious, effective, and generalizable CBGT and buprenorphine hybrid interventions for OUD.
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