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Sponsors and Collaborators: |
University of Oslo The Research Council of Norway |
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Information provided by: | University of Oslo |
ClinicalTrials.gov Identifier: | NCT00204243 |
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 |
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Opiate Addiction |
Drug: Naltrexone Drug: methadone |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Naltrexone Implants Compared to Methadone Maintenance Treatment (MMT) Among Inmates About to be Released From Prison - a Randomized Controlled Trial |
Estimated Enrollment: | 100 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | February 2008 |
Arms | Assigned Interventions |
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1: Experimental
Naltrexone implant (GoMedical Inc. 6 months implant)
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Drug: Naltrexone
GoMedical 6-months implant (approx. 3,6 g naltrexone)
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2: Active Comparator
Methadone Maintenance Treatment
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Drug: methadone
methadone maintenance
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Norway | |
Unit for Addiction Medicine | |
Oslo, Norway, 0407 |
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 |
Study ID Numbers: | Project B: 160115 |
Study First Received: | September 13, 2005 |
Last Updated: | August 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00204243 |
Health Authority: | Norway: Norwegian Medicines Agency |
naltrexone implant methadone inmates randomized controlled trial |
Naphazoline Oxymetazoline Methadone Behavior, Addictive Guaifenesin Phenylephrine |
Mental Disorders Naltrexone Substance-Related Disorders Disorders of Environmental Origin Phenylpropanolamine Opioid-Related Disorders |
Respiratory System Agents Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants Narcotics Pharmacologic Actions Sensory System Agents |
Therapeutic Uses Peripheral Nervous System Agents Analgesics Antitussive Agents Central Nervous System Agents Analgesics, Opioid |