Enablers and hindrances for longer-term abstinence in opioid dependent individuals receiving treatment with extended-release naltrexone: A Norwegian longitudinal recovery trial (NaltRec study)

Abstract

Opioid-dependence is a comprehensive, relapsing disorder with negative individual, - family, - and societal consequences. Recovery is difficult to achieve. Research has shown reduced substance use and improved health- and psychosocial factors with extended-release naltrexone (XR-NTX) treatment. Pharmacological treatment should include psychosocial interventions to improve longer-term recovery. This study explores how voluntary monthly treatment with extended-release naltrexone hydrochloride (Vivitrol®) will influence longer-term recovery, health and psychosocial relationships in opioid-dependent patients. Close relatives’ experiences and societal costs will be assessed. This Norwegian naturalistic, multicenter, open-label study includes 150 opioiddependent patients. Patients are assessed every four weeks for 24 weeks, with 28 weeks optional follow-up treatment-period, and at three, six and 12 months posttreatment. Controls are opioid-dependent patients enrolled in Opioid Maintenance Treatment programs (n = 150). Data on recovery will be collected from participants, close relatives, and community health service providers. Genetic analyses of major signaling pathways and national registries on prescriptions and health care use will be analyzed. Recruitment period is September 2018 to September 2020. The assessment of medical, psychological, relational and societal factors may provide novel in-depth knowledge on the complexity of personal recovery-processes. The results are expected to have impact on priorities in treatment and follow-up for opioid dependent patients.

Keywords

• Extended release naltrexone hydrochloride
• Opioid dependence
• Recovery
• Multicenter clinical trial
• Cost-benefit