Naltrexone Implants as Relapse Prevention

• Status: Terminated
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical trial is to study the efficacy and safety of naltrexone implants as relapse prevention for patients that are completing treatment for opiate addiction in inpatient (or similarly controlled) settings. Participants in the naltrexone experimental group are prematched in a pairwise fashion with other patients who do not want a naltrexone implant during the first six months after ending inpatient treatment, but who reiceive treatment as usual (TAU) from the Norwegian healthcare system.

The hypotheses are that quality of life, depression, opioid use, will be significantly better in the naltrexone group compared to the non at 6-, 12-, and 18-month follow-up.

We also hypothesize that the implants can prevent death from opioid overdose up to 6 months after commenced treatment.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oslo
• Treatments: Naltrexone

Criteria

Inclusion Criteria:

• soon to complete inpatient treatment for opioid addiction

• living in southern Norway

Exclusion Criteria:

• psychosis / major depression, currently not treated

• pregnancy

• liver enzymes: ASAT or ALAT > threefold above upper boundary

• maintenance treatment with methadone or buprenorphine