British Columbia Centre on Substance Use, Vancouver, BC, Canada (GB, KJ, LR); Department of Medicine, University of British Columbia, St. Paul's Hospital, Vancouver, BC, Canada (GB); Department of Sociology, University of British Columbia, Vancouver, BC, Canada (KJ, LR); Department of Medicine, Oregon Health and Science University, 3270 SW Pavilion Loop, Portland, OR (PTK).
J Addict Med. 2021;15(5):390-395. doi: 10.1097/ADM.0000000000000772.
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.
我们进行这项研究是为了了解参与者在一项随机对照试验中对其接受的治疗的看法，该试验旨在研究使用长效纳曲酮治疗物质使用障碍与常规治疗相比的效果。
对参与一项更大规模临床试验的 22 名潜在和实际参与者进行半结构化定性访谈，该试验旨在研究长效纳曲酮治疗艾滋病毒感染者的阿片类药物和酒精使用障碍的可行性。访谈内容被转录、编码，并进行主题分析。
参与者描述他们的研究经历大多是积极的，但同时也持有或发展了对研究药物的担忧和误解。首先，一些参与者描述了对他们接受的治疗的担忧、缺乏控制和不安。其次，一些参与者认为他们的治疗是“安慰剂”，或者确信他们的治疗无效，从而影响了他们对药物使用的看法。第三，一些参与者认为研究治疗是治疗物质使用障碍的万能药。
参与者对试验干预措施的看法可能会影响他们对临床研究的体验和参与。这些发现表明，研究人员和临床医生需要考虑担忧和对药物的接受程度可能如何影响入组和参与者的自主权。它们还确定了在试验设计和实施中加强社区参与的机会，以改善参与者对干预措施性质和潜在持续同意过程的教育，从而促进参与者对研究目的和目标的理解。
