Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction

Phase 2

Completed

• Conditions: Opiate Dependence
• Interventions: Drug: Go Medical Naltrexone implants

• Registration Number: NCT00521157
• Lead Sponsor: University of Oslo

Brief 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 volunteer for the study before being released from inpatient treatment, and are randomized to a naltrexone implant group or a waiting-list control for the duration of the first six months following completion of inpatient treatment. Both groups are free to receive treatment as usual (TAU) from the Norwegian healthcare system. After six months, both groups will be offered to have naltrexone implanted for the remaining six months of the study.

The hypotheses are that quality of life, depression, opioid use, will be significantly better in the naltrexone group compared to the non at 6-month follow-up. For the last six months of the trial, the investigators hypothesise that choice of naltrexone implant will mainly strengthen positive tendencies or reverse negative trends on the aforementioned variables.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-08-24
• Study First Submitted QC: 2007-08-24
• Study First Posted: 2007-08-27
• Primary Completion: 2008-06
• Study Completion: 2008-12
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-04
• Last Update Posted: 2009-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
intervention	Go Medical Naltrexone implants	Experimental group randomised after abstinence oriented treatment

Primary Outcome Measures

Name	Time	Method
Drug use at 6 (12) months by self report and hair analysis	6 and 12 months
Days in work or education	6 and 12 months
Number of drug-free friends at 6 (12) months by self report	6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Depression at 6 (12) months by BDI and Hopkins SCL-25	6 and 12 months
Quality of life at 6 (12) months by EuropASI	6 and 12 months

Trial Locations

Locations (1)

Unit for Addiction Medicine, University of Oslo; 🇳🇴 Oslo, Norway