Naltrexone Implants - a Treatment Alternative for Heroin Dependent Prisoners?
Information source: University of Oslo
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heroin Dependence; Criminal Behaviour
Intervention: Naltrexone implants (Drug); Methadone maintenance (Drug); Unspecified psychosocial rehabilitation (Behavioral)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: University of Oslo
Official(s) and/or principal investigator(s):
Philip Lobmaier, MD, Principal Investigator, Affiliation: University of Oslo, Medical Faulty
Helge Waal, MD, Study Director, Affiliation: University of Oslo, Medical Faulty, Unit for Addcition Medicine
The health service in the prisons in the East region in Oslo screen prisoners for heroin
dependency. Possible candidates are contacted for voluntary participation in the trial.
Those eligible are randomised either to methadone maintenance or to naltrexone implants.
Rehabilitation plans are made for both groups. Status at entrance are investigated with ASI,
MINI, ICL 25 and Becks inventory. Treatment is initiated before release . Status is
investigated at 6 months, 12 months and 18 months with the same instruments and with hair
analyses for drug use. Probands and controls might freely chose treatment at follow up.
Hypothesis is that implants will secure abstinence better than MMT while MMT will have grater
impact on social rehabilitation. Implants will be a valuable supplement for prisoners before
Official title: Naltrexone Implants - a Road From Heroin Dependency. Part B. A Randomised Trial Comparing Methadone and Naltrexone Implants in the Rehabilitation of Heroin Dependent Offenders.
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Use of heroin
Use of other psychoactive substances
Rearrests and criminal behaviour
Mental health (depression, stress indicators)
Quality of life
Minimum age: 18 Years.
Maximum age: N/A.
- Heroin dependency
- Acceptance of trial conditions
- Already on MMT
- Serious depressions
- Active hepatitis
- For females: pregnant
Locations and Contacts
Unit for Addiction Medicine, University of Oslo, Oslo N-0407, Norway
Starting date: May 2005
Ending date: December 2007
Last updated: August 24, 2007