Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00204243
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2005-09-13
Brief Title:
Naltrexone Implants vs MMT Among Inmates in the Norwegian Correctional Services
Sponsor:
University of Oslo
Organization:
University of Oslo
Study Overview
Official Title:
Naltrexone Implants Compared to Methadone Maintenance Treatment MMT Among Inmates About to be Released From Prison - a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None