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Completed

NCT Number: NCT00204243

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

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.

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Key information

Conditions

Opiate Addiction Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Unit for Addiction Medicine

Oslo, 0407, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naltrexone

Drug

surgically implanted naltrexone releasing during 5 to 6 months

Methadone

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Distress / depression: BDI and Hopkins SCL-25

    Time frame: 6, 12 and 18 months

  2. Quality of life, temporary satisfaction with life scale & self report as of ASI

    Time frame: 6, 12 and 18 months

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • The Research Council of Norway

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 20, 2005
Registry last updated
May 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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