Naltrexone Implants - a Treatment Alternative for Heroin Dependent Prisoners?

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 release.

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

Primary outcome:

Use of heroin

Use of other psychoactive substances

Rearrests and criminal behaviour

Secondary outcome:

Mental health (depression, stress indicators)

Quality of life

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Heroin dependency

- Acceptance of trial conditions

Exclusion Criteria:

- Psychosis

- Already on MMT

- Serious depressions

- Active hepatitis

- For females: pregnant

Unit for Addiction Medicine, University of Oslo, Oslo N-0407, Norway

Starting date: May 2005
Ending date: December 2007
Last updated: August 24, 2007