Participants’ Treatment Perspectives on a Clinical Trial on the Use of Extended-Release Naltrexone for Substance Use Disorders: Considerations for Future Clinical Research
Bibliographic record
Abstract
OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.133 | 0.174 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.009 | 0.012 |
| Scholarly communication | 0.009 | 0.008 |
| Open science | 0.002 | 0.007 |
| Research integrity | 0.005 | 0.007 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".