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| ID | Type | Description | Link |
|---|---|---|---|
| 204725-1 | Other Grant/Funding Number | Norwegian Research Council |
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| Name | Class |
|---|---|
| The Research Council of Norway | OTHER |
| The Royal Norwegian Ministry of Health | OTHER |
| Norwegian Institute of Public Health | OTHER_GOV |
| Oslo University Hospital |
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Persons dependent on opioids like heroin, morphine, or codeine have a high risk of relapse, overdose and overdose death. This risk is elevated even further following discharge from treatment or correctional institutions where patients have been detoxified. At the moment, state-of-the-art treatment is based on maintaining the dependence on opioids by daily intake of opioid medications like methadone or buprenorphine. Recently, a medication containing the blocking agent naltrexone was approved in the US; this does not maintain dependence but instead blocks heroin and other opioids for 28 days after intramuscular administration. This study will conduct a 12-week randomized comparison of naltrexone intramuscular suspension (XL-NTX) with daily buprenorphine-naloxone in OMT. Medication will start preceding discharge from a treatment or correctional facility to participating catchment regions in Norway. The main hypotheses are that XL-NTX will do equally well as - or better than - OMT on the proportion of biological samples negative for opioids, retention, self-reported use of alcohol and illicit drugs. Following the 12-week randomized period, there will be a 36-week period where participants can receive the study medication of their choice. After the end of the study, data from national registry databases can be collected for a further 12 months on outcomes such as recidivism, mortality and morbidity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naltrexone intramuscular suspension | Experimental | Extended release naltrexone injections 380mg |
|
| Buprenorphine-naloxone | Active Comparator | Flexible oral dose 4-24 mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone intramuscular suspension | Drug | A standard dosage of 380 mg / month of naltrexone intramuscular suspension will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of biological samples negative/positive for opioid agonists | Week 1-12 post discharge | |
| Retention | Week 1-12 post discharge | |
| Days of use or abstinence from opioids | Week 1-12 post discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Use of other substances of abuse | Week 1-48 | |
| Mental health | Self-reported mental health | Week 1-12 or 1-48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Tanum, MD, PhD | University of Oslo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus University Hospital | Oslo | Akershus | Norway | |||
| Haukeland University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40342086 | Derived | Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3. | |
| 39987958 | Derived | Solli KK, Benth JS, Digranes LCW, Holtan L, Kunoe N, Tanum L. Changes in mental health during long-term treatment with extended-release naltrexone: A 3-year clinical study of opioid dependent individuals. Contemp Clin Trials. 2025 May;152:107861. doi: 10.1016/j.cct.2025.107861. Epub 2025 Feb 21. |
| Label | URL |
|---|---|
| Webpage of the study Sponsor: The Norwegian Centre for Addiction Research, Univ of Oslo | View source |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000624616 | vivitrol |
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| OTHER |
| University Hospital, Akershus | OTHER |
| Haukeland University Hospital | OTHER |
| Helse Stavanger HF | OTHER_GOV |
| The Hospital of Vestfold | OTHER |
| Ostfold Hospital Trust | OTHER |
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|
| Buprenorphine-naloxone | Drug | Buprenorphine-naloxone is administered daily and provided in accordance with existing guidelines for OMT in Norway (treatment-as-usual). |
|
|
| Somatic health |
Self-reported and/or assessed by study personnel |
| Week 1-12 or 1-48 post discharge |
| Psychosocial problems | Psychosocial problems like recidivism, employment, family problems. Self-reported or registry-based. | Week 1-12, Week 1-48, & Wk 49-100 |
| Bergen |
| Hordaland |
| Norway |
| Stavanger University Hospital | Stavanger | Rogaland | Norway |
| Vestfold Hospital Trust | Tønsberg | Vestfold | Norway |
| Oslo University Hospital, Avdeling for Rus og Avhengighet | Oslo | 0407 | Norway |
| 37865138 | Derived | Opheim A, Benth JS, Solli KK, Kloster PS, Fadnes LT, Kunoe N, Gaulen Z, Tanum L. Risk of relapse to non-opioid addictive substances among opioid dependent patients treated with an opioid receptor antagonist or a partial agonist: A randomized clinical trial. Contemp Clin Trials. 2023 Dec;135:107360. doi: 10.1016/j.cct.2023.107360. Epub 2023 Oct 19. |
| 34487395 | Derived | Opheim A, Gaulen Z, Solli KK, Latif ZE, Fadnes LT, Benth JS, Kunoe N, Tanum L. Risk of Relapse Among Opioid-Dependent Patients Treated With Extended-Release Naltrexone or Buprenorphine-Naloxone: A Randomized Clinical Trial. Am J Addict. 2021 Sep;30(5):453-460. doi: 10.1111/ajad.13151. |
| 30701613 | Derived | Latif ZE, Solli KK, Opheim A, Kunoe N, Benth JS, Krajci P, Sharma-Haase K, Tanum L. No increased pain among opioid-dependent individuals treated with extended-release naltrexone or buprenorphine-naloxone: A 3-month randomized study and 9-month open-treatment follow-up study. Am J Addict. 2019 Feb;28(2):77-85. doi: 10.1111/ajad.12859. Epub 2019 Jan 31. |
| 30566177 | Derived | Latif ZE, Saltyte Benth J, Solli KK, Opheim A, Kunoe N, Krajci P, Sharma-Haase K, Tanum L. Anxiety, Depression, and Insomnia Among Adults With Opioid Dependence Treated With Extended-Release Naltrexone vs Buprenorphine-Naloxone: A Randomized Clinical Trial and Follow-up Study. JAMA Psychiatry. 2019 Feb 1;76(2):127-134. doi: 10.1001/jamapsychiatry.2018.3537. |
| 29806872 | Derived | Solli KK, Latif ZE, Opheim A, Krajci P, Sharma-Haase K, Benth JS, Tanum L, Kunoe N. Effectiveness, safety and feasibility of extended-release naltrexone for opioid dependence: a 9-month follow-up to a 3-month randomized trial. Addiction. 2018 Oct;113(10):1840-1849. doi: 10.1111/add.14278. Epub 2018 Jun 22. |
| 29049469 | Derived | Tanum L, Solli KK, Latif ZE, Benth JS, Opheim A, Sharma-Haase K, Krajci P, Kunoe N. Effectiveness of Injectable Extended-Release Naltrexone vs Daily Buprenorphine-Naloxone for Opioid Dependence: A Randomized Clinical Noninferiority Trial. JAMA Psychiatry. 2017 Dec 1;74(12):1197-1205. doi: 10.1001/jamapsychiatry.2017.3206. |
| 27121539 | Derived | Kunoe N, Opheim A, Solli KK, Gaulen Z, Sharma-Haase K, Latif ZE, Tanum L. Design of a randomized controlled trial of extended-release naltrexone versus daily buprenorphine-naloxone for opioid dependence in Norway (NTX-SBX). BMC Pharmacol Toxicol. 2016 Apr 28;17(1):18. doi: 10.1186/s40360-016-0061-1. |
| D006571 |
| Heterocyclic Compounds |
| D009270 | Naloxone |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |