drugset / Trial / NCT03647774
Long Acting Naltrexone for Opioid Addiction: Focus on Sustained Abstinence and Recovery
Phase 4
Completed
317 enrolled
Lars Tanum
Haukeland University Hospital · collabHospital of Southern Norway Trust · collabOslo University Hospital · collabThe Hospital of Vestfold · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study is designed as an open-label evaluation of how treatment with XR-NTX may influence the quality and speed of recovery of opioid dependent individuals - in a context of a naturalistic clinical treatment of opioid dependence. The study will assess recovery outcomes and compare these with the clinical effectiveness of XR-NTX (use of illicit substances and safety). Further, the study will assess the recovery outcomes in matched controls receiving treatment with buprenorphine or buprenorphine-naloxone and enrolled in the national OMT program, and compare this with participants receiving XR-NTX.
Timeline
- Start
- 2018-08-01
- Primary completion
- 2022-10-13
- Completion
- 2022-10-13
Publications
- Juya F, Klemmetsby Solli K, Sannes AC, Weimand B, Gjerstad J, Tanum L, Mordal J. Genetic Influence on Extended-Release Naltrexone Treatment Outcomes in Patients with Opioid Use Disorder: An Exploratory Study. Brain Sci. 2025 Dec 24;16(1):23. doi: 10.3390/brainsci16010023.
- Mordal J, Juya F, Holtan L, Vederhus JK, Opheim A, Brenna IH, Enger AE, Weimand B, Solli KK, Tanum L. High induction rate onto extended-release naltrexone for people with opioid use disorder: experiences from a Norwegian naturalistic study. Addict Sci Clin Pract. 2025 Jun 16;20(1):50. doi: 10.1186/s13722-025-00576-9.
- Marciuch A, Brenna IH, Weimand B, Solli KK, Tanum L, Rostad BK, Birkeland B. Patients' experiences of continued treatment with extended-release naltrexone: a Norwegian qualitative study. Addict Sci Clin Pract. 2022 Jul 18;17(1):36. doi: 10.1186/s13722-022-00317-2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naltrexone | Small molecule | 380 mg | Intramuscular |