Naltrexone Implants vs. MMT Among Inmates in the Norwegian Correctional Services

Phase 2

Completed

• Conditions: Opiate Addiction
• Interventions: Drug: Naltrexone; Drug: Methadone

• Registration Number: NCT00204243
• Lead Sponsor: University of Oslo

Brief Summary

The purpose of this clinical trial is to study the efficacy and safety of naltrexone implants as a relapse prevention for opiate addicted inmates about to be released from prison. The experimental group is compared with a control group that commences methadone maintenance treatment before release.

The hypothesises are that quality of life and criminal behaviour improve significantly in both groups compared to the month before incarceration. The experimental group is going to have significant less days with opioid use compared to the MMT group.

We hypothesize furthermore that the implants can prevent death related to opiate overdose up to 6 months after commenced treatment.

Detailed Description

The probability of quick relapse to criminal activity and substance abuse after prison release is high among incarcerated opiate addicts.

We attempt to prevent relapse to opiate abuse by two different means:

Methadone Maintenance Treatment (MMT) versus Naltrexone implants, randomly allocated to two groups by sealed envelopes.

All participants may choose in which group to continue after 6 (and again after 12) months, when the implants supposedly stop releasing naltrexone.

The total treatment period is 18 months, continuation with MMT is optional after study termination.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-20
• Primary Completion: 2008-02
• Study Completion: 2008-12
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-18
• Last Update Posted: 2011-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• opiate addiction
• living in greater Oslo area

Exclusion Criteria

• psychosis / major depression, currently not treated
• pregnancy
• liver enzymes: ASAT or ALAT > threefold above upper boundary

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naltrexone implant	Naltrexone	Naltrexone implant (GoMedical Inc. 6 months implant)
Methadone	Methadone	Methadone Maintenance Treatment

Primary Outcome Measures

Name	Time	Method
Drug use: self reported, urin / hair analysis	6, 12 and 18 months	Use of heroin and other illicit drugs, self reported and in hair analyses

Secondary Outcome Measures

Name	Time	Method
Quality of life, temporary satisfaction with life scale & self report as of ASI	6, 12 and 18 months
Distress / depression: BDI and Hopkins SCL-25	6, 12 and 18 months

Trial Locations

Locations (1)

Unit for Addiction Medicine; 🇳🇴 Oslo, Norway