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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Opiate Addiction

Intervention / Treatment
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* Drug: Naltrexone
* Drug: Methadone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naltrexone implant<br>Naltrexone implant (GoMedical Inc. 6 months implant) | Drug: Naltrexone<br>* surgically implanted naltrexone releasing during 5 to 6 months<br>|
| Active Comparator: Methadone<br>Methadone Maintenance Treatment | Drug: Methadone<br>* Methadone maintenance treatment, flexible high dose (80 to 120 mg / Day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distress / depression: BDI and Hopkins SCL-25 |  | 6, 12 and 18 months | 
| Quality of life, temporary satisfaction with life scale & self report as of ASI |  | 6, 12 and 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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naltrexone implant, methadone, inmates, randomized controlled trial