Naltrexone vs Buprenorphine-Naloxone for Opioid Dependence in Norway (NTX-SBX)

University of Oslo

Status and phase

Completed

Phase 3

Conditions

Opioid Dependence

Treatments

Drug: Naltrexone intramuscular suspension

Drug: Buprenorphine-naloxone

Study type

Interventional

Funder types

Other

Identifiers

NCT01717963

2011-002858-31

204725-1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

166 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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