Opiate Addiction Clinical Trial
Official title:
Naltrexone Implants Compared to Methadone Maintenance Treatment (MMT) Among Inmates About to be Released From Prison - a Randomized Controlled Trial
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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