Naltrexone vs Buprenorphine-Naloxone for Opioid Dependence in Norway
Status:
Completed
Trial end date:
2018-04-30
Target enrollment:
Participant gender:
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
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