Naltrexone vs Buprenorphine-Naloxone for Opioid Dependence in Norway
- Conditions
- Opioid Dependence
- Interventions
- Drug: Buprenorphine-naloxone
- Registration Number
- NCT01717963
- Lead Sponsor
- University of Oslo
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 166
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Naltrexone intramuscular suspension Naltrexone intramuscular suspension Extended release naltrexone injections 380mg Buprenorphine-naloxone Buprenorphine-naloxone Flexible oral dose 4-24 mg daily
- Primary Outcome Measures
Name Time Method Number of biological samples negative/positive for opioid agonists Week 1-12 post discharge Retention Week 1-12 post discharge Days of use or abstinence from opioids Week 1-12 post discharge
- Secondary Outcome Measures
Name Time Method Mental health Week 1-12 or 1-48 Self-reported mental health
Somatic health Week 1-12 or 1-48 post discharge Self-reported and/or assessed by study personnel
Use of other substances of abuse Week 1-48 Psychosocial problems Week 1-12, Week 1-48, & Wk 49-100 Psychosocial problems like recidivism, employment, family problems. Self-reported or registry-based.
Trial Locations
- Locations (5)
Stavanger University Hospital
🇳🇴Stavanger, Rogaland, Norway
Akershus University Hospital
🇳🇴Oslo, Akershus, Norway
Vestfold Hospital Trust
🇳🇴Tonsberg, Vestfold, Norway
Haukeland University Hospital
🇳🇴Bergen, Hordaland, Norway
Oslo University Hospital, Avdeling for Rus og Avhengighet
🇳🇴Oslo, Norway