Naltrexone Implants as Relapse Prevention

Phase 3TerminatedNCT00269607

University of Oslo12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Opioid Dependency

Interventions

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Primary Outcomes: drug use at 6(12/18)months by self report, hair analysis; days in work or education, number of drug-free friends at 6 (12/18)months by self report

Secondary Outcomes

Secondary Outcomes: depression at 6(12/18)months by BDI and Hopkins SCL-25; quality of life at 6(12/18)months by EuropASI