Participants' Treatment Perspectives on a Clinical Trial on the Use of Extended-Release Naltrexone for Substance Use Disorders: Considerations for Future Clinical Research.

Abstract

We undertook this study to understand participants' perceptions of their assigned treatment in a randomized control trial examining the use of extended-release naltrexone versus treatment as usual for substance use disorders. Semi-structured qualitative interviews among 22 prospective and actual participants in a larger clinical trial examining the feasibility of extended-release naltrexone for both opioid and alcohol use disorders among people living with HIV. Interviews were transcribed, coded, and analyzed thematically. Participants described their study experience as mostly positive, but also concurrently held or developed study medication apprehensions and misperceptions. First, some participants described apprehension, lack of control, and uneasiness regarding their assigned treatment. Second, some participants perceived their treatment as "placebos" and/or were convinced that their treatment was ineffective, shaping perceptions of impact on their substance use. Third, some participants perceived study treatments as cure-alls for substance use disorders. Participant perceptions of trial interventions may frame their experience and participation in clinical studies. These findings demonstrate the need for researchers and clinicians to consider how apprehension and a lack of medication receptivity may impact enrollment and participant autonomy. They also identify opportunities for greater community engagement in trial design and implementation in order to improve participant education about the nature of interventions and the potential of ongoing consent processes integrated throughout studies to promote participant understandings of study purposes and objectives.