Naltrexone vs Buprenorphine-Naloxone for Opioid Dependence in Norway

• Status: Completed
• Trial end date: 2018-04-30
• Target enrollment: 0
• Participant gender: All

Summary

Persons dependent on opioids like heroin, morphine, or codeine have a high risk of relapse, overdose and overdose death. This risk is elevated even further following discharge from treatment or correctional institutions where patients have been detoxified. At the moment, state-of-the-art treatment is based on maintaining the dependence on opioids by daily intake of opioid medications like methadone or buprenorphine. Recently, a medication containing the blocking agent naltrexone was approved in the US; this does not maintain dependence but instead blocks heroin and other opioids for 28 days after intramuscular administration. This study will conduct a 12-week randomized comparison of naltrexone intramuscular suspension (XL-NTX) with daily buprenorphine-naloxone in OMT. Medication will start preceding discharge from a treatment or correctional facility to participating catchment regions in Norway. The main hypotheses are that XL-NTX will do equally well as - or better than - OMT on the proportion of biological samples negative for opioids, retention, self-reported use of alcohol and illicit drugs. Following the 12-week randomized period, there will be a 36-week period where participants can receive the study medication of their choice. After the end of the study, data from national registry databases can be collected for a further 12 months on outcomes such as recidivism, mortality and morbidity.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oslo
• Collaborators: Haukeland University Hospital; Helse Stavanger HF; Norwegian Institute of Public Health; Oslo University Hospital; Ostfold Hospital Trust; The Hospital of Vestfold; The Research Council of Norway; The Royal Norwegian Ministry of Health; University Hospital, Akershus
• Treatments: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone; Naltrexone

Criteria

Inclusion Criteria:

• Opioid dependence (DSM-IV TR)

• 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:

• Pregnant or breast-feeding

• 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