Naltrexone Implants vs. MMT Among Inmates in the Norwegian Correctional Services - Full Text View

Sponsor:	University of Oslo
Collaborator:	The Research Council of Norway
Information provided by:	University of Oslo
ClinicalTrials.gov Identifier:	NCT00204243

Purpose

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.

Condition	Intervention	Phase
Opiate Addiction	Drug: Naltrexone Drug: Methadone	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Naltrexone Implants Compared to Methadone Maintenance Treatment (MMT) Among Inmates About to be Released From Prison - a Randomized Controlled Trial

Resource links provided by NLM:

Drug Information available for: Naltrexone Naltrexone hydrochloride Methadone Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by University of Oslo:

Primary Outcome Measures:

Drug use: self reported, urin / hair analysis [ Time Frame: 6, 12 and 18 months ] [ Designated as safety issue: No ]
Use of heroin and other illicit drugs, self reported and in hair analyses

Secondary Outcome Measures:

Distress / depression: BDI and Hopkins SCL-25 [ Time Frame: 6, 12 and 18 months ] [ Designated as safety issue: No ]
Quality of life, temporary satisfaction with life scale & self report as of ASI [ Time Frame: 6, 12 and 18 months ] [ Designated as safety issue: No ]

Enrollment:	46
Study Start Date:	May 2005
Study Completion Date:	December 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Naltrexone implant Naltrexone implant (GoMedical Inc. 6 months implant)	Drug: Naltrexone surgically implanted naltrexone releasing during 5 to 6 months
Active Comparator: Methadone Methadone Maintenance Treatment	Drug: Methadone Methadone maintenance treatment, flexible high dose (80 to 120 mg / Day)

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204243

Locations

Norway
Unit for Addiction Medicine
Oslo, Norway, 0407

Sponsors and Collaborators

University of Oslo

The Research Council of Norway

Investigators

Principal Investigator:	Philipp Lobmaier, cand. med.	Unit for Addiction Medicine
Study Director:	Helge Waal, professor	Unit for Addiction Medicine, University of Oslo
Study Chair:	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

More Information

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

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kunøe N, Lobmaier P, Vederhus JK, Hjerkinn B, Gossop M, Hegstad S, Kristensen Ø, Waal H. Challenges to antagonist blockade during sustained-release naltrexone treatment. Addiction. 2010 Sep;105(9):1633-9.

Responsible Party:	Philipp Lobmaier, University of Oslo
ClinicalTrials.gov Identifier:	NCT00204243 History of Changes
Obsolete Identifiers:	NCT00520793
Other Study ID Numbers:	Project B: 160115
Study First Received:	September 13, 2005
Last Updated:	May 18, 2011
Health Authority:	Norway: Norwegian Medicines Agency

Keywords provided by University of Oslo:

naltrexone implant
methadone
inmates
randomized controlled trial

Additional relevant MeSH terms:

Behavior, Addictive
Opioid-Related Disorders
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Mental Disorders
Naltrexone
Methadone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Analgesics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012