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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
46
surgically implanted naltrexone releasing during 5 to 6 months
Methadone maintenance treatment, flexible high dose (80 to 120 mg / Day)
Unit for Addiction Medicine
Oslo, Norway
Drug use: self reported, urin / hair analysis
Use of heroin and other illicit drugs, self reported and in hair analyses
Time frame: 6, 12 and 18 months
Distress / depression: BDI and Hopkins SCL-25
Time frame: 6, 12 and 18 months
Quality of life, temporary satisfaction with life scale & self report as of ASI
Time frame: 6, 12 and 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.