NaltRec-study
Long acting naltrexone for individuals with opioid addiction
Extended-release naltrexone injections (XR-NTX) represent a novel treatment option for opioid dependence, effectively blocking the euphoric effects of heroin and other opioids while preventing opioid overdoses. In contrast to methadone or buprenorphine treatment, XR-NTX therapy assists patients in abstaining from opioids over an extended period.
About the trial
The aim of the project is to investigate the effectiveness and tolerance of extended-release naltrexone (XR-NTX) in the treatment of individuals with opioid dependence. In this project, we examine how long-term abstinence from opioids affects mental and physical health, its potential contribution to personal recovery processes, and the effectiveness and safety of XR-NTX treatment in a clinical, naturalistic setting. This will be conducted using an open, non-randomized study design, where results from the group of patients treated with XR-NTX will be compared with a group of patients receiving standard opioid agonist treatment (OAT). This control group will be matched to the treatment group based on age and gender.
The study participants have given their consent to data from registeries being collected after study participation has been completed. Two studies on long-acting Naltrexone have been conducted in Norway. Firstly, the XR-NTX vs BP-NLX study under the auspices of SERAF, and 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 Ahus and SERAF researcher Kristin Klemmetsby Solli at Kristin.klemmetsby.solli@ahus.no or k.k.solli@medisin.uio.no.
Scientific title
Long acting naltrexone for opioid addiction: the importance of mental, physical and societal factors for sustained abstinence and recovery
Read about the trial
Project page in Cristin (Current research information system in Norway)Information about participation
Recruitment is over
Who can participate?
The study included 317 adult individuals with opioid dependence. Half of them were offered voluntary treatment with the study medication XR-NTX after detoxification, while the other half received standard opioid agonist treatment (OAT) based on clinical indication. The control group will only be compared to the study patients on recovery-related outcome measures. Substance use among the control group will not be recorded in the study. Participants choose their preferred treatment but must commit to complete abstinence if they opt for the study medication. All participants must be approved for OAT. Additionally, there are several inclusion and exclusion criteria. Data collection has been completed.
Collaboration partners
Cooperation with
- Akershus universitetssykehus
- Helse Bergen
- Sørlandet sykehus
- Sykehuset i Vestfold