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

NCT00204243 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2011-05-19

No results posted yet for this study

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.

Conditions

  • Opiate Addiction

Interventions

DRUG

Naltrexone

surgically implanted naltrexone releasing during 5 to 6 months

DRUG

Methadone

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

Sponsors & Collaborators

  • The Research Council of Norway

    collaborator OTHER

  • University of Oslo

    lead OTHER

Principal Investigators

  • Philipp Lobmaier, cand. med. · Unit for Addiction Medicine

  • Helge Waal, professor · Unit for Addiction Medicine, University of Oslo

  • Michael Abdelnoor, PhD · Ullevål University Hospital, Centre for clinical research

  • Jørg Mørland, professor · Division of Forensic Toxicology and Drug Abuse

  • Asbjørg S Christophersen, MD · Division of Forensic Toxicology and Drug Abuse

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2008-02-29
Completion
2008-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00204243 on ClinicalTrials.gov