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

This study has been completed.
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by:
University of Oslo
ClinicalTrials.gov Identifier:
NCT00204243
First received: September 13, 2005
Last updated: May 18, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Opiate Addiction
 Drug: Naltrexone
Drug: Methadone
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Naltrexone Implants Compared to Methadone Maintenance Treatment (MMT) Among Inmates About to be Released From Prison - a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • Drug use: self reported, urin / hair analysis [ Time Frame: 6, 12 and 18 months ] [ Designated as safety issue: No ]
    Use of heroin and other illicit drugs, self reported and in hair analyses


Secondary Outcome Measures:
  • Distress / depression: BDI and Hopkins SCL-25 [ Time Frame: 6, 12 and 18 months ] [ Designated as safety issue: No ]
  • Quality of life, temporary satisfaction with life scale & self report as of ASI [ Time Frame: 6, 12 and 18 months ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: May 2005
Study Completion Date: December 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204243

Locations
Norway
Unit for Addiction Medicine
Oslo, Norway, 0407
Sponsors and Collaborators
University of Oslo
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
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Philipp Lobmaier, University of Oslo
ClinicalTrials.gov Identifier: NCT00204243     History of Changes
Obsolete Identifiers: NCT00520793
Other Study ID Numbers: Project B: 160115
Study First Received: September 13, 2005
Last Updated: May 18, 2011
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by University of Oslo:
naltrexone implant
methadone
inmates
randomized controlled trial

Additional relevant MeSH terms:
Behavior, Addictive
Opioid-Related Disorders
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Mental Disorders
Naltrexone
Methadone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Analgesics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on May 16, 2013