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

NCT00204243 | Completed Phase 2 DMC

• 1 other identifier: Project B: 160115
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opiate Addiction

Keywords

naltrexone implant; methadone; inmates; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Drug use: self reported, urin / hair analysis

  Use of heroin and other illicit drugs, self reported and in hair analyses

  6, 12 and 18 months

Secondary Outcomes (2)

• Distress / depression: BDI and Hopkins SCL-25

  6, 12 and 18 months

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

  6, 12 and 18 months

Study Arms (2)

Naltrexone implant

EXPERIMENTAL

Naltrexone implant (GoMedical Inc. 6 months implant)

Drug: Naltrexone

Methadone

ACTIVE COMPARATOR

Methadone Maintenance Treatment

Drug: Methadone

Interventions

Naltrexone DRUG

surgically implanted naltrexone releasing during 5 to 6 months

Naltrexone implant

Methadone DRUG

Methadone maintenance treatment, flexible high dose (80 to 120 mg / Day)

Methadone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• opiate addiction
• living in greater Oslo area

You may not qualify if:

• psychosis / major depression, currently not treated
• pregnancy
• liver enzymes: ASAT or ALAT \> threefold above upper boundary

Sponsors & Collaborators

• University of Oslo: lead
• The Research Council of Norway: collaborator

Study Sites (1)

Unit for Addiction Medicine

Oslo, 0407, Norway

Location

Related Publications (8)

• 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.

  PMID: 15203441 BACKGROUND

• 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.

  PMID: 15203440 BACKGROUND

• 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.

  PMID: 15899557 BACKGROUND

• 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.

  PMID: 15255807 BACKGROUND

• Bachs L, Waal H. [Naltrexone in the treatment of addiction]. Tidsskr Nor Laegeforen. 2003 Jun 12;123(12):1665-7. Norwegian.

  PMID: 12821984 BACKGROUND

• 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.

  PMID: 12821982 BACKGROUND

• 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.

  PMID: 40342086 DERIVED

• 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.

  PMID: 20707781 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Naltrexone; Methadone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Ketones; Organic Chemicals

Study Officials

• Philipp Lobmaier, cand. med.

  Unit for Addiction Medicine

  PRINCIPAL INVESTIGATOR

• Helge Waal, professor

  Unit for Addiction Medicine, University of Oslo

  STUDY DIRECTOR

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: May 1, 2005
• Primary Completion: February 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 19, 2011

Record last verified: 2011-05

Locations

NO (1)