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Effectiveness of Injectable Extended-Release Naltrexone vs Daily Buprenorphine-Naloxone for Opioid Dependence: A Randomized Clinical Noninferiority Trial
Open accessAbstract
Importance: To date, extended-release naltrexone hydrochloride has not previously been compared directly with opioid medication treatment (OMT), currently the most commonly prescribed treatment for opioid dependence. Objective: To determine whether treatment with extended-release naltrexone will be as effective as daily buprenorphine hydrochloride with naloxone hydrochloride in maintaining abstinence from heroin and other illicit substances in newly detoxified individuals. Design, Setting and Participants: A 12-week, multicenter, outpatient, open-label randomized clinical trial was conducted at 5 urban addiction clinics in Norway between November 1, 2012, and December 23, 2015; the last follow-up was performed on October 23, 2015. A total of 232 adult opioid-dependent (per DSM-IV criteria) individuals were recruited from outpatient addiction clinics and detoxification units and assessed for eligibility. Intention-to-treat analyses of efficacy end points were performed with all randomized participants. Interventions: Randomization to either daily oral flexible dose buprenorphine-naloxone, 4 to 24 mg/d, or extended-release naltrexone hydrochloride, 380 mg, administered intramuscularly every fourth week for 12 weeks. Main Outcomes and Measures: Primary end points (protocol) were the randomized clinical trial completion rate, the proportion of opioid-negative urine drug tests, and number of days of use of heroin and other illicit opioids. Secondary end points included number of days of use of other illicit substances. Safety was assessed by adverse event reporting. Results: Of 159 participants, mean (SD) age was 36 (8.6) years and 44 (27.7%) were women. Eighty individuals were randomized to extended-release naltrexone and 79 to buprenorphine-naloxone; 105 (66.0%) completed the trial. Retention in the extended-release naltrexone group was noninferior to the buprenorphine-naloxone group (difference, -0.1; with 95% CI, -0.2 to 0.1; P = .04), with mean (SD) time of 69.3 (25.9) and 63.7 (29.9) days, correspondingly (P = .33, log-rank test). Treatment with extended-release naltrexone showed noninferiority to buprenorphine-naloxone on group proportion of total number of opioid-negative urine drug tests (mean [SD], 0.9 [0.3] and 0.8 [0.4], respectively, difference, 0.1 with 95% CI, -0.04 to 0.2; P < .001) and use of heroin (mean difference, -3.2 with 95% CI, -4.9 to -1.5; P < .001) and other illicit opioids (mean difference, -2.7 with 95% CI, -4.6 to -0.9; P < .001). Superiority analysis showed significantly lower use of heroin and other illicit opioids in the extended-release naltrexone group. No significant differences were found between the treatment groups regarding most other illicit substance use. Conclusions and Relevance: Extended-release naltrexone was as effective as buprenorphine-naloxone in maintaining short-term abstinence from heroin and other illicit substances and should be considered as a treatment option for opioid-dependent individuals. Trial Registration: clinicaltrials.gov Identifier: NCT01717963.
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“It is possible that inverse agonism of μ and κ-opioid receptors may help to restrict the potential for abuse of (2R,6R)-HNK similar to how naltrexone helps prevent relapse in opioid and alcohol use disorders, however this assertion requires further research”
From Mechanisms of ketamine and its metabolites as antidepressants (2022) · cites this paper as Tanum et al., 2017
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Metadata
- Authors
- Tanum, L., Solli, K. K., Latif, Z.-E.-H., Benth, J. Š., Opheim, A., Sharma-Haase, K., Krajci, P., & Kunøe, N.
- Affiliations
- University of Oslo (NO)
- Akershus University Hospital (NO)
- Institute of Clinical Medicine, Campus Ahus, University of Oslo, Oslo, Norway4Health Services Research Unit, Akershus University Hospital, Lorenskog, Norway
- Haukeland University Hospital (NO)
- The Norwegian Centre for Addiction Research, The University of Oslo, Oslo, Norway7Department of Addiction Medicine, Vestfold Hospital Trust, Tonsberg, Norway
- Department of Addiction Medicine, Oslo University Hospital, Oslo, Norway
- Corresponding author
- Tanum, Lars
- Venue
- JAMA Psychiatry
- Publisher
- American Medical Association (AMA)
- Published
- 2017-12-01
- Volume
- 74
- Issue
- 12
- Pages
- 1197
- ISSN
- 2168-622X (ISSN-L)
- PMC
- PMC6583381
- OpenAlex
- W2766969415
- Cited by
- 253
- References
- 43
- Citations by year
- 2026: 13 · 2025: 21 · 2024: 20 · 2023: 15 · 2022: 25 · 2021: 34 · 2020: 30 · 2019: 47 · 2018: 44 · 2017: 4
- FWCI
- 32.10
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA Psychiatry (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Norges Forskningsråd
- Haukeland Universitetssjukehus
- Akershus Universitetssykehus
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Opioid Use Disorder Treatment
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Opioid Use
- Keywords
- buprenorphine/naloxone, opioid use disorder, heroin use, opioid substitution therapy, abstinence, treatment retention, detoxification, intramuscular injection, non-inferiority, illicit drug use, treatment safety, addiction treatment centers, Norway
- MeSH terms
- Buprenorphine, Naloxone Drug Combination, Administration, Oral, Adult, Delayed-Action Preparations, Female, Humans, Injections, Intramuscular, Male, Naloxone, Narcotic Antagonists, Opioid-Related Disorders, Psychiatric Status Rating Scales, Substance Abuse Detection, Treatment Outcome, Drug Monitoring, Diagnostic and Statistical Manual of Mental Disorders, Opiate Substitution Treatment
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