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Development of a Methamphetamine Early Intervention

Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT01174654
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
127
Enrollment
1
Location
2
Arms
28
Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Methamphetamine abuse has a strong and consistent epidemiologic association with high-risk sexual behavior and both prevalent and incident HIV in men who have sex with men (MSM), and some authorities have advocated methamphetamine treatment as an HIV prevention strategy. However, methamphetamine interventions have not been evaluated in controlled trials, nor have they been implemented and assessed outside of substance abuse treatment programs. This application proposes preliminary investigations to adapt a methamphetamine treatment intervention previously associated with decreased sexual-risk taking among MSM for use as an early intervention among MSM in Seattle, Washington. Sixty methamphetamine-using MSM will be enrolled in a randomized controlled trial of contingency management (CM) versus no intervention. CM participants will have their urine tested for methamphetamine 3 times weekly for 12 weeks, and will receive vouchers of escalating value when their urines test negative; vouchers will be withheld when participants' urines test positive for methamphetamine or participants miss urine testing visits. All participants will undergo urine methamphetamine testing and audio-computer assisted self-interviews on sexual behavior and substance use at baseline and at 6 week intervals for 6 months. Participants will be tested for HIV, syphilis, rectal gonorrhea and chlamydial infection, and pharyngeal gonorrhea at baseline and at 3 and 6 month follow-up. The study will determine how often MSM will initiate and complete the early intervention, and will longitudinally measure unsafe sexual behaviors among intervention and control participants. Study results will determine the feasibility of instituting and studying CM as an early intervention; define whether the intervention is sufficiently promising to justify a larger, definitive randomized controlled trial; and will provide estimates for defining the number of participants such a trial would require.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Contingency management
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
127 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Prevention
Official Title:
Development of a Methamphetamine Early Intervention
Study Start Date :
Dec 1, 2006
Actual Primary Completion Date :
Apr 1, 2009
Actual Study Completion Date :
Apr 1, 2009

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Referral to community resources
Experimental: Contingency Management

Behavioral: Contingency management
A 12-week contingency management intervention
Other Names:
  • Voucher-based reinforcement

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Non-concordant unprotected anal intercourse [Baseline, 6, 12, 18, 24 weeks]

    Secondary Outcome Measures

    1. Number of non-concordant unprotected anal intercourse partners [Baseline, 6, 12, 18, 24 weeks]

    2. Stimulant (methamphetamine and crack/cocaine) urinalyses [Baseline, 6, 12, 18, 24 weeks]

    3. Self-reported methamphetamine use [Baseline, 6, 12, 18, 24 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Anal sex with another man in the month prior to enrollment

    • Use of methamphetamine on at least 2 days in the month prior to enrollment

    Exclusion Criteria:

    • Plans to move from the study catchment area within 6 months of enrollment

    • A mutually monogamous relationships with a man of the same HIV status lasting 2 or more years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lifelong AIDS Alliance Seattle Washington United States 98122

    Sponsors and Collaborators

    • University of Washington
    • National Institute on Drug Abuse (NIDA)

    Investigators

    • Principal Investigator: Matthew Golden, University of Washington

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Washington
    ClinicalTrials.gov Identifier:
    NCT01174654
    Other Study ID Numbers:
    • R21DA019420-01A1
    • R21DA019420-01A1
    First Posted:
    Aug 3, 2010
    Last Update Posted:
    Dec 13, 2012
    Last Verified:
    Dec 1, 2012

    Study Results

    No Results Posted as of Dec 13, 2012