Naltrexone Implants as Relapse Prevention

University of Oslo

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Opioid Dependency

Treatments: Drug: Implantation of naltrexone implants

Study type: Interventional

Funder types: Other

Identifiers

NCT00269607

11899

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)