At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 46 enrolled

Drug / intervention

Naltrexone +1 moredrug

Likely dose

Methadone 120 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00204243

NCT00204243Phase 2Completed

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Naltrexone Implants Compared to Methadone Maintenance Treatment (MMT) Among Inmates About to be Released From Prison - a Randomized Controlled Trial

University of Oslo·interventional·Posted Sep 20, 2005·Updated May 19, 2011

In Brief

A Phase 2 clinical trial evaluating Naltrexone and Methadone for Opiate Addiction. Completed, enrolled 46 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsOpiate Addiction

CountriesNorway

CollaboratorsThe Research Council of Norway

Timeline

Phase 2CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMay 2005

First PostedSep 2005

Primary CompletionFeb 2008

Study CompletionDec 2008

TodayJul 2026

First PostedSep 20, 2005

Enrollment StartMay 1, 2005

Primary CompletionFeb 1, 2008

Study CompletionDec 1, 2008

TodayJul 2, 2026

Enrollment to primary: 2.8 yearsPosted 20.8 years ago

Interventions

Naltrexonedrug

surgically implanted naltrexone releasing during 5 to 6 months

Methadonedrug

Methadone maintenance treatment, flexible high dose (80 to 120 mg / Day)