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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00204243

Enrollment

Registered

2005-09-20

Start date

2005-05-31

Completion date

2008-12-31

Last updated

2011-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opiate Addiction

Keywords

naltrexone implant, methadone, inmates, randomized controlled trial

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.

Interventions

DRUGNaltrexone

surgically implanted naltrexone releasing during 5 to 6 months

DRUGMethadone

Methadone maintenance treatment, flexible high dose (80 to 120 mg / Day)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Drug use: self reported, urin / hair analysis	6, 12 and 18 months	Use of heroin and other illicit drugs, self reported and in hair analyses

Secondary

Measure	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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026