Naltrexone vs Buprenorphine-Naloxone for Opioid Dependence in Norway

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.

Conditions

• Opioid Dependence

Interventions

DRUG

Naltrexone intramuscular suspension

A standard dosage of 380 mg / month of naltrexone intramuscular suspension will be administered

DRUG

Buprenorphine-naloxone

Buprenorphine-naloxone is administered daily and provided in accordance with existing guidelines for OMT in Norway (treatment-as-usual).

Sponsors & Collaborators

• The Research Council of Norway

  collaborator OTHER

• The Royal Norwegian Ministry of Health

  collaborator OTHER

• Norwegian Institute of Public Health

  collaborator OTHER_GOV

• Oslo University Hospital

  collaborator OTHER

• University Hospital, Akershus

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• Helse Stavanger HF

  collaborator OTHER_GOV

• The Hospital of Vestfold

  collaborator OTHER

• Ostfold Hospital Trust

  collaborator OTHER

• University of Oslo

  lead OTHER

Principal Investigators

• Lars Tanum, MD, PhD · University of Oslo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-10-31

Primary Completion

2016-08-31

Completion

2018-04-30

Countries

• Norway

Study Locations