NCT00204243

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: University of Oslo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opiate Addiction

Interventions

Type	Name	Description
DRUG	Naltrexone	surgically implanted naltrexone releasing during 5 to 6 months
DRUG	Methadone	Methadone maintenance treatment, flexible high dose (80 to 120 mg / Day)

Timeline

• Start date: 2005-05-01
• Primary completion: 2008-02-01
• Completion: 2008-12-01
• First posted: 2005-09-20
• Last updated: 2011-05-19

Locations

1 site across 1 country: Norway