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Development of a Methamphetamine Early Intervention

NCT ID: NCT01174654

Last Updated: 2012-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Sexual Behavior Methamphetamine Behavioral Research

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Referral to community resources

Group Type NO_INTERVENTION

No interventions assigned to this group

Contingency Management

Group Type EXPERIMENTAL

Contingency management

Intervention Type BEHAVIORAL

A 12-week contingency management intervention

Interventions

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Contingency management

A 12-week contingency management intervention

Intervention Type BEHAVIORAL

Other Intervention Names

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Voucher-based reinforcement

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Golden

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Lifelong AIDS Alliance

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Menza TW, Jameson DR, Hughes JP, Colfax GN, Shoptaw S, Golden MR. Contingency management to reduce methamphetamine use and sexual risk among men who have sex with men: a randomized controlled trial. BMC Public Health. 2010 Dec 20;10:774. doi: 10.1186/1471-2458-10-774.

Reference Type DERIVED
PMID: 21172026 (View on PubMed)

Other Identifiers

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R21DA019420-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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R21DA019420-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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