Trial reportContemporary clinical trials2016
NIDA Clinical Trials Network CTN-0051, Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (X:BOT): Study design and rationale.
Trial report in Contemporary clinical trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02032433 (CTN-0051), which is not on this map. Cited by 45 papers, 3 of them syntheses that pooled it.
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.
CTN-0051: Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
Who cites it
45 citing papers in PubMed, 3 syntheses or guidelines pooled it, 61 citations in OpenAlex.
- Sustained-release naltrexone for opioid dependence.The Cochrane database of systematic reviews · 2025Pooled it
- Opioid agonist treatment for people who are dependent on pharmaceutical opioids.The Cochrane database of systematic reviews · 2022Pooled it
- Extended-release injectable naltrexone for opioid use disorder: a systematic review.Addiction (Abingdon, England) · 2018Pooled it
- 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
- Buprenorphine-naloxone vs. extended-release naltrexone for opioid use disorder in individuals with and without criminal legal involvement: A secondary analysis of the X:BOT randomized controlled trial.Journal of substance use and addiction treatment · 2024Trial
- Polysubstance use before and during treatment with medication for opioid use disorder: Prevalence and association with treatment outcomes.Journal of substance abuse treatment · 2022Trial
- 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
- Cost-effectiveness implications of increasing the efficiency of the extended-release naltrexone induction process for the treatment of opioid use disorder: a secondary analysis.Addiction (Abingdon, England) · 2021Trial
- Naturalistic follow-up after a trial of medications for opioid use disorder: Medication status, opioid use, and relapse.Journal of substance abuse treatment · 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
- Optimizing opioid use disorder treatment with naltrexone or buprenorphine.Drug and alcohol dependence · 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
- HIV-Risk Behavior Among Adults with Opioid Use Disorder During 12 Months Following Pre-trial Detention: Results from a Randomized Trial of Methadone Treatment.AIDS and behavior · 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
- Health-related quality of life and opioid use disorder pharmacotherapy: A secondary analysis of a clinical trial.Drug and alcohol dependence · 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
- Cost of pharmacotherapy for opioid use disorders following inpatient detoxification.The American journal of managed care · 2018Trial
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 8 institutions in 1 country.
Funding
Abstract
introductionFor opioid-dependent patients in the US and elsewhere, detoxification and counseling-only aftercare are treatment mainstays. Long-term abstinence is rarely achieved; many patients relapse and overdose after detoxification. Methadone, buprenorphine-naloxone (BUP-NX) and extended-release naltrexone (XR-NTX) can prevent opioid relapse but are underutilized. This study is intended to develop an evidence-base to help patients and providers make informed choices and to foster wider adoption of relapse-prevention pharmacotherapies.
methodsThe National Institute on Drug Abuse's Clinical Trials Network (CTN) study CTN-0051, X:BOT, is a comparative effectiveness study of treatment for 24weeks with XR-NTX, an opioid antagonist, versus BUP-NX, a high affinity partial opioid agonist, for opioid dependent patients initiating treatment at 8 short-term residential (detoxification) units and continuing care as outpatients. Up to 600 participants are randomized (1:1) to XR-NTX or BUP-NX.
resultsThe primary outcome is time to opioid relapse (i.e., loss of persistent abstinence) across the 24-week treatment phase. Differences between arms in the distribution of time-to-relapse will be compared (construction of the asymptotic 95% CI for the hazard ratio of the difference between arms). Secondary outcomes include proportions retained in treatment, rates of opioid abstinence, adverse events, cigarette, alcohol, and other drug use, and HIV risk behaviors; opioid cravings, quality of life, cognitive function, genetic moderators, and cost effectiveness.
conclusionsXR-NTX and BUP-NX differ considerably in their characteristics and clinical management; no studies to date have compared XR-NTX with buprenorphine maintenance. Study design choices and compromises inherent to a comparative effectiveness trial of distinct treatment regimens are reviewed. CLINICAL
trial registrationNCT02032433.
Indexed as
Identifiers
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.