Back to resultsNaltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction
Primary Purpose
Opiate Dependence
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Go Medical Naltrexone implants
Sponsored by
About this trial
This is an interventional treatment trial for Opiate Dependence focused on measuring Substance abuse, Opiate dependency, Treatment, Relapse prevention
Eligibility Criteria
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
Sites / Locations
- Unit for Addiction Medicine, University of Oslo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention
2
Arm Description
Experimental group randomised after abstinence oriented treatment
waiting list control
Outcomes
Primary Outcome Measures
Drug use at 6 (12) months by self report and hair analysis
Days in work or education
Number of drug-free friends at 6 (12) months by self report
Secondary Outcome Measures
Depression at 6 (12) months by BDI and Hopkins SCL-25
Quality of life at 6 (12) months by EuropASI
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00521157
Brief Title
Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction
Official Title
Naltrexone Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction - a Randomised Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Oslo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence
Keywords
Substance abuse, Opiate dependency, Treatment, Relapse prevention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Experimental
Arm Description
Experimental group randomised after abstinence oriented treatment
Arm Title
2
Arm Type
No Intervention
Arm Description
waiting list control
Intervention Type
Drug
Intervention Name(s)
Go Medical Naltrexone implants
Other Intervention Name(s)
Go Medical naltrexone implant
Intervention Description
Naltrexone implants 3.2 g (double of 1,6 g)
Primary Outcome Measure Information:
Title
Drug use at 6 (12) months by self report and hair analysis
Time Frame
6 and 12 months
Title
Days in work or education
Time Frame
6 and 12 months
Title
Number of drug-free friends at 6 (12) months by self report
Time Frame
6 and 12 months
Secondary Outcome Measure Information:
Title
Depression at 6 (12) months by BDI and Hopkins SCL-25
Time Frame
6 and 12 months
Title
Quality of life at 6 (12) months by EuropASI
Time Frame
6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helge Waal, Professor
Organizational Affiliation
Unit for addiction medicine, Institute of psychiatry, University of Oslo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Helge Waal, MD
Organizational Affiliation
Norwegian Medical Association
Official's Role
Study Director
Facility Information:
Facility Name
Unit for Addiction Medicine, University of Oslo
City
Oslo
ZIP/Postal Code
N-0407
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
20707781
Citation
Kunoe N, Lobmaier P, Vederhus JK, Hjerkinn B, Gossop M, Hegstad S, Kristensen O, Waal H. Challenges to antagonist blockade during sustained-release naltrexone treatment. Addiction. 2010 Sep;105(9):1633-9. doi: 10.1111/j.1360-0443.2010.03031.x.
Results Reference
derived
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Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction
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