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Study of Naltrexone for Methamphetamine Addiction

Sponsor
California Pacific Medical Center Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00984360
Collaborator
(none)
22
Enrollment
1
Location
2
Arms
36
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Pilot Trial of Naltrexone for Methamphetamine Addiction - Role of the A118G SNP
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: A118G

Drug: Naltrexone
380mg extended-release, given once by intramuscular gluteal injection
Other Names:
  • Vivitrol
  • Vivitrex

    		•
    Experimental: Wild-type

    Drug: Naltrexone
    380mg extended-release, given once by intramuscular gluteal injection
    Other Names:
  • Vivitrol
  • Vivitrex

    		•

    Outcome Measures

    Primary Outcome Measures

    1. MA (-) Urine Samples [Twice weekly for 5 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age between 18 and 50 years

    • Patient is agreeable to conditions of study and signs consent form

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Addiction & Pharmacology Research Laboratory San Francisco California United States 94110

    Sponsors and Collaborators

    • California Pacific Medical Center Research Institute

    Investigators

    • Principal Investigator: John Mendelson, MD, California Pacific Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    John Mendelson, MD, Senior Scientist, California Pacific Medical Center Research Institute
    ClinicalTrials.gov Identifier:
    NCT00984360
    Other Study ID Numbers:
    • 1R01DA027161-01
    First Posted:
    Sep 25, 2009
    Last Update Posted:
    May 31, 2013
    Last Verified:
    May 1, 2013
    Keywords provided by John Mendelson, MD, Senior Scientist, California Pacific Medical Center Research Institute
    Meth
    Methamphetamine Addiction
    Methamphetamine Treatment
    Naltrexone
    Vivitrol
    A118G
    OPRM1
    Additional relevant MeSH terms:
    Behavior, Addictive
    Naltrexone

    Study Results

    No Results Posted as of May 31, 2013