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

University of Oslo

Status and phase: Completed; Phase 2

Conditions: Opiate Addiction

Treatments: Drug: Methadone; Drug: Naltrexone

Study type: Interventional

Funder types: Other

Identifiers

NCT00204243

Project B: 160115

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Naltrexone implant

Experimental group

Description:

Naltrexone implant (GoMedical Inc. 6 months implant)

Treatment:

Drug: Naltrexone

Methadone

Active Comparator group

Description:

Methadone Maintenance Treatment

Treatment:

Drug: Methadone