ArticleContemporary clinical trials2016
Ethical and clinical safety considerations in the design of an effectiveness trial: A comparison of buprenorphine versus naltrexone treatment for opioid dependence.
Article in Contemporary clinical trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
27 citing papers in PubMed, 33 citations in OpenAlex.
- Suicidal ideation in adults with opioid use disorder treated with buprenorphine-naloxone versus extended-release naltrexone.The American journal of drug and alcohol abuse · 2025Trial
- Association between dynamic dose increases of buprenorphine for treatment of opioid use disorder and risk of relapse.Addiction (Abingdon, England) · 2022Trial
- Longitudinal study of impact of medication for opioid use disorder on Hamilton Depression Rating Scale.Journal of affective disorders · 2022Trial
- Patient Characteristics Associated with Opioid Abstinence after Participation in a Trial of Buprenorphine versus Injectable Naltrexone.Substance use & misuse · 2022Trial
- Naturalistic follow-up after a trial of medications for opioid use disorder: Medication status, opioid use, and relapse.Journal of substance abuse treatment · 2021Trial
- Optimizing opioid use disorder treatment with naltrexone or buprenorphine.Drug and alcohol dependence · 2021Trial
- Reductions in tobacco use in naltrexone, relative to buprenorphine-maintained individuals with opioid use disorder: Secondary analysis from the National Drug Abuse Treatment Clinical Trials Network.Journal of substance abuse treatment · 2021Trial
- Examination of Correlates of OUD Outcomes in Young Adults: Secondary Analysis From the XBOT Trial.The American journal on addictions · 2021Trial
- Sublingual Buprenorphine-Naloxone Compared With Injection Naltrexone for Opioid Use Disorder: Potential Utility of Patient Characteristics in Guiding Choice of Treatment.The American journal of psychiatry · 2021Trial
- An alternative analysis of illicit opioid use during treatment in a randomized trial of extended-release naltrexone versus buprenorphine-naloxone: A per-protocol and completers analysis.Drug and alcohol dependence · 2021Trial
- Extended-release naltrexone versus buprenorphine-naloxone to treat opioid use disorder among black adults.Addictive behaviors · 2020Trial
- Trajectory classes of opioid use among individuals in a randomized controlled trial comparing extended-release naltrexone and buprenorphine-naloxone.Drug and alcohol dependence · 2019Trial
- Comparative effectiveness of extended-release naltrexone versus buprenorphine-naloxone for opioid relapse prevention (X:BOT): a multicentre, open-label, randomised controlled trial.Lancet (London, England) · 2018Trial
- Treatment Trajectories During and After a Medication Trial for Opioid Use Disorder: Moving from Research as Usual to Treatment as Usual.Journal of addiction medicineTrial
- Modeling Recurrent Events: A Tutorial Based on Relapse and Remitting Episodes during Medication-Assisted Treatment for Opioid Use Disorder.Medical decision making : an international journal of the Society for Medical Decision Making · 2026Article
- Long acting injectable buprenorphine: Perspectives from service-users, staff and stakeholders.Drug and alcohol dependence reports · 2025Article
- Impact of Medication-Based Treatment on Health Care Utilization Among Individuals With Opioid Use Disorder.Psychiatric services (Washington, D.C.) · 2023Article
- Optimally Choosing Medication Type for Patients With Opioid Use Disorder.American journal of epidemiology · 2023Article
- Time-lagged association between counseling and/or 12-Step attendance with subsequent opioid use in a secondary analysis from a randomized, clinical trial of medications for opioid use disorder.Drug and alcohol dependence reports · 2022Article
- Population-level impact of initiating pharmacotherapy and linking to care people with opioid use disorder at inpatient medically managed withdrawal programs: an effectiveness and cost-effectiveness analysis.Addiction (Abingdon, England) · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 6 institutions in 1 country.
Funding
Abstract
We examine ethical challenges encountered in the design of an effectiveness trial (CTN-0051; X:BOT), comparing sublingual buprenorphine-naloxone (BUP-NX), an established treatment for opioid dependence, to the newer extended-release injectable naltrexone (XR-NTX). Ethical issues surrounded: 1) known poor effectiveness of one possible, commonly used treatment as usual control condition-detoxification followed by counseling without medication; 2) the role of patients' preferences for treatments, given that treatments were clinically approved and available to the population; 3) differences between the optimal "usual treatment" clinical settings for different treatments making it challenging to design a fair comparison; 4) vested interest groups favoring different treatments exerting potential influence on the design process; 5) potentially vulnerable populations of substance users and prisoners; 6) potential therapeutic misconception in the implementation of safety procedures; and 7) high cost of a large trial limiting questions that could be addressed. We examine how the design features underlying these ethical issues are characteristic of effectiveness trials, which are often large trials that compare treatments with varying degrees of existing effectiveness data and familiarity to patients and clinicians, in community-based treatment settings, with minimal exclusion criteria that could involve vulnerable populations. Hence, investigators designing effectiveness trials may wish to remain alert to the possibility of similar ethical issues.
Indexed as
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.