About the project
Remaining abstinent from heroin without the use of methadone or other OMT medication is very difficult in the long term.
This study compares a long-acting intramuscular formulation of naltrexone with the current first choice in OMT, buprenorphine-naloxone, in an exploratory, randomized multicentre study.
The study has been led by Lars Tanum and Nikolaj Kunøe in cooperation with participating hospitals.
The study has been approved by the Regional Committees for Medical and Health Research Ethics (REK) and the Norwegian Medicines Agency, and has been monitored by a clinical monitor (CTU at Oslo University Hospital and Innovest).
Inclusion and follow-up of study participants took place in the period from 2012 to 2018. The study participants consented to the collection of registry data subsequent to the completion of their participation in the study.
Two studies on long-acting Naltrexone have been conducted in Norway. This study under the auspices of SERAF, as well as the NaltRec study led by Akershus University Hospital (Ahus). Both studies are led by Professor Lars Tanum. Existing data from these two studies will be compiled, and the data will be cross-linked with data from various registries. The purpose of this linkage is to acquire knowledge to assess whether long-acting Naltrexone can be an effective and safe treatment option over time.
The University of Oslo with SERAF and Ahus have a joint responsibility for the compilation of existing data and registry data and are, in this regard, obliged to fulfill the participants' privacy rights according to GDPR Chapter 3. These privacy rights include, among other things, maintaining confidentiality, as well as ensuring the secure storage and processing of sensitive data. For questions related to this research, contact SERAF and Ahus researcher Kristin Klemmetsby Solli
Doctoral theses published as a result of this research:
Kristin Klemmetsby Solli (2018)
Research findings
- The study showed that long-acting Naltrexone was at least as effective as buprenorphine-naloxone with regards to retention in treatment, as well as in the reduction of opioid and other substance use in a 3-month RCT.
- Long-acting Naltrexone proved to be a safe and effective treatment option for opioid dependence over a period of up to 3 years.
- In several published articles, many outcomes of treatment with long-acting Naltrexone have been examined, including changes in pain issues, mental health, opioid craving, quality of life, and treatment satisfaction. These studies support long-acting Naltrexone as a good treatment option for opioid dependence.
Financing
- Akershus University Hospital
- Oslo University Hospital
- The Research Council of Norway Program for Clinical Research
- SERAF, UiO
- Vestfold Hospital Trust
Collaborations
- Akershus University Hospital
- Haukeland University Hospital
- Oslo University Hospital
- Stavanger University Hospital/KORFOR
- Vestfold Hospital
- Østfold Hospital
Publications
- Gaulen, Z., Šaltytė Benth, J., Fadnes, L. T., Brenna, I. H., & Tanum, L. (2022). Life satisfaction among individuals with opioid use disorder receiving extended-release naltrexone: A 12-week randomized controlled trial and a 36-week follow-up. J Subst Abuse Treat, 135, 108656
- Gaulen, Z., Brenna, I. H., Fadnes, L. T., Saltyte Benth, J, Solli, K. K., Kunoe, N., Tanum, L. (2021). The Predictive Value of Degree of Preference for Extended-Release Naltrexone for Treatment Adherence, Opioid Use, and Relapse. Eur Addict Res, 1-12.
- Opheim, A., Gaulen, Z., Solli, K. K., Latif, Z. E., Fadnes, L.T., Benth, J. S.,Tanum, L. (2021). Risk of Relapse Among Opioid-Dependent Patients Treated With Extended-Release Naltrexone or Buprenorphine-Naloxone: A Randomized Clinical Trial. Am J Addict, 30(5), 453-460.
- Solli, K. K., Opheim, A., Latif, Z. E., Krajci, P., Benth, JŠ, Kunoe, N., & Tanum, L. (2020). Adapting treatment length to opioid-dependent individuals' needs and preferences: A 2-year follow-up to a 1-year study of extended-release naltrexone. Addiction, 116, 8, 2084-93.
- Solli, K. K., Kunoe, N., Latif, Z.-e.-H., Sharma-Haase, K., Opheim, A., Krajci, P., Gaulen, Z., Saltyte Benth, J., & Tanum, L. (2019). Availability of Extended-Release Naltrexone May Increase the Number of Opioid-Dependent Individuals in Treatment: Extension of a Randomized Clinical Trial. Eur Addict Res, 25(6):303-309
- Latif, Z.-e.-H., Solli, K. K., Opheim, A., Kunoe, N., Benth, J. Š., Krajci, P., Sharma Haase, K., & Tanum, L. (2019). 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. The American Journal of Addictions. Feb;28(2):77-85.
- Latif, Z. E., Saltyte Benth, J., Solli, K. K., Opheim, A., Kunoe, N., Krajci, P., Sharma Haase, K., & Tanum, L. (2018). 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. 76(2): 127–134.
- Solli, K. K., Latif, Z. E., Opheim, A., Krajci, P., Sharma Haase, K., Tanum, L., & Kunoe, N. (2018). Effectiveness, safety and feasibility of extended-release naltrexone for opioid dependence: a nine-month follow-up to a three-month randomized trial. Addiction, 113(10): 1840-49.
- Tanum L, Solli KK, Latif ZE, Benth JS, Opheim A, Sharma-Haase K, Krajci,P., & Kunoe, N. (2017) Effectiveness of Injectable Extended-Release Naltrexone vs Daily Buprenorphine-Naloxone for Opioid Dependence: A Randomized Clinical Noninferiority Trial. JAMA Psychiatry. 2017;74(12):1197-205.
- Sharma Haase K, Kunoe N, Opheim A, Gaulen Z, Nja AM, Latif ZE, Solli, K.K., & Tanum, L. (2016) Interest in Extended Release Naltrexone among Opioid Users. European addiction research. 2016;22(6):301-5.
- Kunøe, N., Opheim, A., Solli, K. K., Gaulen, Z., Sharma-Haase, K., Latif, Z. E., & Tanum, L. (2016). Design of a randomized controlled trial of extended-release naltrexone versus daily buprenorphine-naloxone for opioid dependence in Norway (NTX-SBX). BMC Pharmacology and Toxicology, 17(1), 1-10.