Back to resultsStudy of Naltrexone for Methamphetamine Addiction
Primary Purpose
Methamphetamine Dependence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Naltrexone
Sponsored by
About this trial
This is an interventional treatment trial for Methamphetamine Dependence focused on measuring Meth, Methamphetamine Addiction, Methamphetamine Treatment, Naltrexone, Vivitrol, A118G, OPRM1
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 50 years
- Patient is agreeable to conditions of study and signs consent form
Sites / Locations
- Addiction & Pharmacology Research Laboratory
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A118G
Wild-type
Arm Description
Outcomes
Primary Outcome Measures
MA (-) Urine Samples
Secondary Outcome Measures
Full Information
NCT ID
NCT00984360
First Posted
September 14, 2009
Last Updated
May 29, 2013
Sponsor
California Pacific Medical Center Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00984360
Brief Title
Study of Naltrexone for Methamphetamine Addiction
Official Title
A Pilot Trial of Naltrexone for Methamphetamine Addiction - Role of the A118G SNP
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California Pacific Medical Center Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether methamphetamine-dependent individuals will use less methamphetamine when treated with naltrexone. The study will also investigate whether individuals with the mu opioid receptor gene variant A118G will use less methamphetamine than individuals without A118G.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methamphetamine Dependence
Keywords
Meth, Methamphetamine Addiction, Methamphetamine Treatment, Naltrexone, Vivitrol, A118G, OPRM1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A118G
Arm Type
Experimental
Arm Title
Wild-type
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Other Intervention Name(s)
Vivitrol, Vivitrex
Intervention Description
380mg extended-release, given once by intramuscular gluteal injection
Primary Outcome Measure Information:
Title
MA (-) Urine Samples
Time Frame
Twice weekly for 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 50 years
Patient is agreeable to conditions of study and signs consent form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Mendelson, MD
Organizational Affiliation
California Pacific Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addiction & Pharmacology Research Laboratory
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Naltrexone for Methamphetamine Addiction
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