This trial is active, not recruiting.

Condition opioid dependence
Treatments naltrexone intramuscular suspension, buprenorphine-naloxone
Phase phase 3
Sponsor University of Oslo
Collaborator The Research Council of Norway
Start date October 2012
End date May 2016
Trial size 166 participants
Trial identifier NCT01717963, 2011-002858-31, 204725-1


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Extended release naltrexone injections 380mg
naltrexone intramuscular suspension Long-acting naltrexone
A standard dosage of 380 mg / month of naltrexone intramuscular suspension will be administered
(Active Comparator)
Flexible oral dose 4-24 mg daily
buprenorphine-naloxone Suboxone
Buprenorphine-naloxone is administered daily and provided in accordance with existing guidelines for OMT in Norway (treatment-as-usual).

Primary Outcomes

Number of biological samples negative/positive for opioid agonists
time frame: Week 1-12 post discharge
time frame: Week 1-12 post discharge
Days of use or abstinence from opioids
time frame: Week 1-12 post discharge

Secondary Outcomes

Use of other substances of abuse
time frame: Week 1-48
Mental health
time frame: Week 1-12 or 1-48
Somatic health
time frame: Week 1-12 or 1-48 post discharge
Psychosocial problems
time frame: Week 1-12, Week 1-48, & Wk 49-100

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Optimal Prevention of Overdose Deaths and Opioid Relapse Following Discharge: A Multi-Center RCT of Naltrexone Versus Buprenorphine in Norway
Principal investigator Lars Tanum, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University of Oslo.