Naltrexone Implants vs. MMT Among Inmates in the Norwegian Correctional Services
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.
|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|
- 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
- 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 ]
|Study Start Date:||May 2005|
|Study Completion Date:||December 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Experimental: Naltrexone implant
Naltrexone implant (GoMedical Inc. 6 months implant)
surgically implanted naltrexone releasing during 5 to 6 months
Active Comparator: Methadone
Methadone Maintenance Treatment
Methadone maintenance treatment, flexible high dose (80 to 120 mg / Day)
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.
|Unit for Addiction Medicine|
|Oslo, Norway, 0407|
|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|