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

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ClinicalTrials.gov Identifier: NCT00204243
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 19, 2011
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by:
University of Oslo

Brief 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.


Condition or disease Intervention/treatment Phase
Opiate Addiction Drug: Naltrexone Drug: Methadone Phase 2

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  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2005
Actual Primary Completion Date : February 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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)



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
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
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: May 19, 2011
Last Verified: May 2011

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

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Methadone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Antitussive Agents
Respiratory System Agents