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

Primary Purpose

Opiate Addiction

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Naltrexone
Methadone
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Opiate Addiction focused on measuring naltrexone implant, methadone, inmates, randomized controlled trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Unit for Addiction Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Naltrexone implant

Methadone

Arm Description

Naltrexone implant (GoMedical Inc. 6 months implant)

Methadone Maintenance Treatment

Outcomes

Primary Outcome Measures

Drug use: self reported, urin / hair analysis
Use of heroin and other illicit drugs, self reported and in hair analyses

Secondary Outcome Measures

Distress / depression: BDI and Hopkins SCL-25
Quality of life, temporary satisfaction with life scale & self report as of ASI

Full Information

First Posted
September 13, 2005
Last Updated
May 18, 2011
Sponsor
University of Oslo
Collaborators
The Research Council of Norway
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1. Study Identification

Unique Protocol Identification Number
NCT00204243
Brief Title
Naltrexone Implants vs. MMT Among Inmates in the Norwegian Correctional Services
Official Title
Naltrexone Implants Compared to Methadone Maintenance Treatment (MMT) Among Inmates About to be Released From Prison - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Oslo
Collaborators
The Research Council of Norway

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Addiction
Keywords
naltrexone implant, methadone, inmates, randomized controlled trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Naltrexone implant
Arm Type
Experimental
Arm Description
Naltrexone implant (GoMedical Inc. 6 months implant)
Arm Title
Methadone
Arm Type
Active Comparator
Arm Description
Methadone Maintenance Treatment
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Intervention Description
surgically implanted naltrexone releasing during 5 to 6 months
Intervention Type
Drug
Intervention Name(s)
Methadone
Intervention Description
Methadone maintenance treatment, flexible high dose (80 to 120 mg / Day)
Primary Outcome Measure Information:
Title
Drug use: self reported, urin / hair analysis
Description
Use of heroin and other illicit drugs, self reported and in hair analyses
Time Frame
6, 12 and 18 months
Secondary Outcome Measure Information:
Title
Distress / depression: BDI and Hopkins SCL-25
Time Frame
6, 12 and 18 months
Title
Quality of life, temporary satisfaction with life scale & self report as of ASI
Time Frame
6, 12 and 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp Lobmaier, cand. med.
Organizational Affiliation
Unit for Addiction Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helge Waal, professor
Organizational Affiliation
Unit for Addiction Medicine, University of Oslo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michael Abdelnoor, PhD
Organizational Affiliation
Ullevål University Hospital, Centre for clinical research
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jørg Mørland, professor
Organizational Affiliation
Division of Forensic Toxicology and Drug Abuse
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Asbjørg S Christophersen, MD
Organizational Affiliation
Division of Forensic Toxicology and Drug Abuse
Official's Role
Study Chair
Facility Information:
Facility Name
Unit for Addiction Medicine
City
Oslo
ZIP/Postal Code
0407
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
15203441
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. doi: 10.1080/13556210410001674112.
Results Reference
background
PubMed Identifier
15203440
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. doi: 10.1080/13556210410001674103.
Results Reference
background
PubMed Identifier
15899557
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. doi: 10.1016/j.drugalcdep.2005.02.009.
Results Reference
background
PubMed Identifier
15255807
Citation
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.
Results Reference
background
PubMed Identifier
12821984
Citation
Bachs L, Waal H. [Naltrexone in the treatment of addiction]. Tidsskr Nor Laegeforen. 2003 Jun 12;123(12):1665-7. Norwegian.
Results Reference
background
PubMed Identifier
12821982
Citation
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.
Results Reference
background
PubMed Identifier
20707781
Citation
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.
Results Reference
derived

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

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