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

Opiate Addiction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00204243
• Other study ID #: Project B: 160115
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: May 18, 2011
• Start date: May 2005
• Est. completion date: December 2008

Study information

• Verified date: May 2011
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00520793

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Opiate Addiction

Intervention

Drug:
• Naltrexone
surgically implanted naltrexone releasing during 5 to 6 months
• Methadone
Methadone maintenance treatment, flexible high dose (80 to 120 mg / Day)

Locations

Country	Name	City	State
Norway	Unit for Addiction Medicine	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
University of Oslo	The Research Council of Norway

Country where clinical trial is conducted

Norway, 

References & Publications (6)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Distress / depression: BDI and Hopkins SCL-25		6, 12 and 18 months	No
Secondary	Quality of life, temporary satisfaction with life scale & self report as of ASI		6, 12 and 18 months	No