Naltrexone vs Buprenorphine-Naloxone for Opioid Dependence in Norway
NCT ID: NCT01717963
Last Updated: 2018-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
166 participants
INTERVENTIONAL
2012-10-31
2018-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Naltrexone intramuscular suspension
Extended release naltrexone injections 380mg
Naltrexone intramuscular suspension
A standard dosage of 380 mg / month of naltrexone intramuscular suspension will be administered
Buprenorphine-naloxone
Flexible oral dose 4-24 mg daily
Buprenorphine-naloxone
Buprenorphine-naloxone is administered daily and provided in accordance with existing guidelines for OMT in Norway (treatment-as-usual).
Interventions
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Naltrexone intramuscular suspension
A standard dosage of 380 mg / month of naltrexone intramuscular suspension will be administered
Buprenorphine-naloxone
Buprenorphine-naloxone is administered daily and provided in accordance with existing guidelines for OMT in Norway (treatment-as-usual).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 or above
* Applied \& Approved for Norway's national OMT program
* Discharge within 30 days of inclusion from a controlled environment; e.g. inpatient treatment or correctional (prison) facility
* Voluntarily seeking treatment for opioid dependence
Exclusion Criteria
* Acute or recurring severe psychiatric disorder, e.g. psychosis, suicidality
* Serious debilitation of liver or renal function (e.g. Child-Pugh level C)
* Use of excluded medication
* Known intolerance to study drugs or their ingredients
* Employment in firm manufacturing one of the study drugs or close relation to such person
18 Years
ALL
No
Sponsors
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The Research Council of Norway
OTHER
The Royal Norwegian Ministry of Health
OTHER
Norwegian Institute of Public Health
OTHER_GOV
Oslo University Hospital
OTHER
University Hospital, Akershus
OTHER
Haukeland University Hospital
OTHER
Helse Stavanger HF
OTHER_GOV
The Hospital of Vestfold
OTHER
Ostfold Hospital Trust
OTHER
University of Oslo
OTHER
Responsible Party
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Lars Tanum
National Coordinating Investigator (PI)
Principal Investigators
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Lars Tanum, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oslo
Locations
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Akershus University Hospital
Oslo, Akershus, Norway
Haukeland University Hospital
Bergen, Hordaland, Norway
Stavanger University Hospital
Stavanger, Rogaland, Norway
Vestfold Hospital Trust
Tønsberg, Vestfold, Norway
Oslo University Hospital, Avdeling for Rus og Avhengighet
Oslo, , Norway
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Webpage of the study Sponsor: The Norwegian Centre for Addiction Research, Univ of Oslo
Other Identifiers
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204725-1
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2011-002858-31
Identifier Type: -
Identifier Source: org_study_id
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