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

May 18, 2011 updated by: University of Oslo

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

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 Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0407
        • Unit for Addiction Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Naltrexone implant
Naltrexone implant (GoMedical Inc. 6 months implant)
Drug: Naltrexone
surgically implanted naltrexone releasing during 5 to 6 months
Active Comparator: Methadone
Methadone Maintenance Treatment
Drug: Methadone
Methadone maintenance treatment, flexible high dose (80 to 120 mg / Day)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo

Collaborators

The Research Council of Norway

Investigators

  • Principal Investigator: Philipp Lobmaier, cand. med., Unit for Addiction Medicine
  • Study Director: Helge Waal, professor, Unit for Addiction Medicine, University of Oslo
  • Study Chair: Michael Abdelnoor, PhD, Ullevål University Hospital, Centre for clinical research
  • Study Chair: Jørg Mørland, professor, Division of Forensic Toxicology and Drug Abuse
  • Study Chair: Asbjørg S Christophersen, MD, Division of Forensic Toxicology and Drug Abuse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

May 19, 2011

Last Update Submitted That Met QC Criteria

May 18, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Project B: 160115

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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