We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov Menu

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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: September 20, 2005
Last Update Posted: May 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
The Research Council of Norway
Information provided by:
University of Oslo

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
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

Resource links provided by NLM:

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 ]
    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 ]
  • Quality of life, temporary satisfaction with life scale & self report as of ASI [ Time Frame: 6, 12 and 18 months ]

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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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

Unit for Addiction Medicine
Oslo, Norway, 0407
Sponsors and Collaborators
University of Oslo
The Research Council of Norway
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 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 Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: May 19, 2011
Last Verified: May 2011

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

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