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

Information source: University of Oslo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Opiate Addiction

Intervention: Naltrexone (Drug); Methadone (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of Oslo

Official(s) and/or principal investigator(s):
Philipp Lobmaier, cand. med., Principal Investigator, Affiliation: Unit for Addiction Medicine
Helge Waal, professor, Study Director, Affiliation: Unit for Addiction Medicine, University of Oslo
Michael Abdelnoor, PhD, Study Chair, Affiliation: Ullevål University Hospital, Centre for clinical research
Jørg Mørland, professor, Study Chair, Affiliation: Division of Forensic Toxicology and Drug Abuse
Asbjørg S Christophersen, MD, Study Chair, Affiliation: Division of Forensic Toxicology and Drug Abuse


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.

Clinical Details

Official title: Naltrexone Implants Compared to Methadone Maintenance Treatment (MMT) Among Inmates About to be Released From Prison - a Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Drug use: self reported, urin / hair analysis

Secondary outcome:

Distress / depression: BDI and Hopkins SCL-25

Quality of life, temporary satisfaction with life scale & self report as of ASI

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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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

Locations and Contacts

Unit for Addiction Medicine, Oslo 0407, Norway
Additional Information

Related publications:

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.

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.

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.

Olsen L, Christophersen AS, Frogopsahl G, Waal H, Mørland J. Plasma concentrations during naltrexone implant treatment of opiate-dependent patients. Br J Clin Pharmacol. 2004 Aug;58(2):219-22.

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, Mørland J. [Naltrexone implants--a pilot project]. Tidsskr Nor Laegeforen. 2003 Jun 12;123(12):1660-1. Norwegian.

Starting date: May 2005
Last updated: May 18, 2011

Page last updated: August 23, 2015

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