- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00521157
Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction
Naltrexone Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction - a Randomised Study
The purpose of this clinical trial is to study the efficacy and safety of naltrexone implants as relapse prevention for patients that are completing treatment for opiate addiction in inpatient (or similarly controlled) settings. Participants volunteer for the study before being released from inpatient treatment, and are randomized to a naltrexone implant group or a waiting-list control for the duration of the first six months following completion of inpatient treatment. Both groups are free to receive treatment as usual (TAU) from the Norwegian healthcare system. After six months, both groups will be offered to have naltrexone implanted for the remaining six months of the study.
The hypotheses are that quality of life, depression, opioid use, will be significantly better in the naltrexone group compared to the non at 6-month follow-up. For the last six months of the trial, the investigators hypothesise that choice of naltrexone implant will mainly strengthen positive tendencies or reverse negative trends on the aforementioned variables.
The investigators also hypothesize that the implants can prevent death from opioid overdose up to 6 months after commenced treatment.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
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Oslo, Norway, N-0407
- Unit for Addiction Medicine, University of Oslo
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- soon to complete inpatient treatment for opioid addiction
- living in southern Norway
Exclusion Criteria:
- psychosis/major depression, currently not treated
- pregnancy
- liver enzymes: ASAT or ALAT > threefold above upper boundary
- maintenance treatment with methadone or buprenorphine
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: intervention
Experimental group randomised after abstinence oriented treatment
|
Naltrexone implants 3.2 g (double of 1,6 g)
Other Names:
|
No Intervention: 2
waiting list control
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Drug use at 6 (12) months by self report and hair analysis
Time Frame: 6 and 12 months
|
6 and 12 months
|
Days in work or education
Time Frame: 6 and 12 months
|
6 and 12 months
|
Number of drug-free friends at 6 (12) months by self report
Time Frame: 6 and 12 months
|
6 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Depression at 6 (12) months by BDI and Hopkins SCL-25
Time Frame: 6 and 12 months
|
6 and 12 months
|
Quality of life at 6 (12) months by EuropASI
Time Frame: 6 and 12 months
|
6 and 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Helge Waal, professor, Unit for addiction medicine, Institute of psychiatry, University of Oslo
- Study Director: Helge Waal, MD, Norwegian Medical Association
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Substance-Related Disorders
- Disease Attributes
- Narcotic-Related Disorders
- Recurrence
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Sensory System Agents
- Narcotic Antagonists
- Alcohol Deterrents
- Naltrexone
Other Study ID Numbers
- 11899 revised
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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