Naltrexone Implants vs. MMT Among Inmates in the Norwegian Correctional Services
NCT ID: NCT00204243
Last Updated: 2011-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
2005-05-31
2008-12-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Naltrexone implant
Naltrexone implant (GoMedical Inc. 6 months implant)
Naltrexone
surgically implanted naltrexone releasing during 5 to 6 months
Methadone
Methadone Maintenance Treatment
Methadone
Methadone maintenance treatment, flexible high dose (80 to 120 mg / Day)
Interventions
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Naltrexone
surgically implanted naltrexone releasing during 5 to 6 months
Methadone
Methadone maintenance treatment, flexible high dose (80 to 120 mg / Day)
Eligibility Criteria
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Inclusion Criteria
* living in greater Oslo area
Exclusion Criteria
* pregnancy
* liver enzymes: ASAT or ALAT \> threefold above upper boundary
18 Years
65 Years
ALL
No
Sponsors
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The Research Council of Norway
OTHER
University of Oslo
OTHER
Responsible Party
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University of Oslo
Principal Investigators
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Philipp Lobmaier, cand. med.
Role: PRINCIPAL_INVESTIGATOR
Unit for Addiction Medicine
Helge Waal, professor
Role: STUDY_DIRECTOR
Unit for Addiction Medicine, University of Oslo
Michael Abdelnoor, PhD
Role: STUDY_CHAIR
Ullevål University Hospital, Centre for clinical research
Jørg Mørland, professor
Role: STUDY_CHAIR
Division of Forensic Toxicology and Drug Abuse
Asbjørg S Christophersen, MD
Role: STUDY_CHAIR
Division of Forensic Toxicology and Drug Abuse
Locations
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Unit for Addiction Medicine
Oslo, , Norway
Countries
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References
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Hulse GK, Arnold-Reed DE, O'Neil G, Chan CT, Hansson RC. Achieving long-term continuous blood naltrexone and 6-beta-naltrexol coverage following sequential naltrexone implants. Addict Biol. 2004 Mar;9(1):67-72. doi: 10.1080/13556210410001674112.
Hulse GK, Arnold-Reed DE, O'Neil G, Chan CT, Hansson R, O'Neil P. Blood naltrexone and 6-beta-naltrexol levels following naltrexone implant: comparing two naltrexone implants. Addict Biol. 2004 Mar;9(1):59-65. doi: 10.1080/13556210410001674103.
Hulse GK, Tait RJ, Comer SD, Sullivan MA, Jacobs IG, Arnold-Reed D. Reducing hospital presentations for opioid overdose in patients treated with sustained release naltrexone implants. Drug Alcohol Depend. 2005 Sep 1;79(3):351-7. doi: 10.1016/j.drugalcdep.2005.02.009.
Olsen L, Christophersen AS, Frogopsahl G, Waal H, Morland J. Plasma concentrations during naltrexone implant treatment of opiate-dependent patients. Br J Clin Pharmacol. 2004 Aug;58(2):219-22. doi: 10.1111/j.1365-2125.2004.02122.x.
Bachs L, Waal H. [Naltrexone in the treatment of addiction]. Tidsskr Nor Laegeforen. 2003 Jun 12;123(12):1665-7. Norwegian.
Waal H, Christophersen AS, Frogopsahl G, Olsen LH, Morland J. [Naltrexone implants--a pilot project]. Tidsskr Nor Laegeforen. 2003 Jun 12;123(12):1660-1. Norwegian.
Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3.
Kunoe N, Lobmaier P, Vederhus JK, Hjerkinn B, Gossop M, Hegstad S, Kristensen O, Waal H. Challenges to antagonist blockade during sustained-release naltrexone treatment. Addiction. 2010 Sep;105(9):1633-9. doi: 10.1111/j.1360-0443.2010.03031.x.
Other Identifiers
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Project B: 160115
Identifier Type: -
Identifier Source: org_study_id
NCT00520793
Identifier Type: -
Identifier Source: nct_alias
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