Development of a Methamphetamine Early Intervention - Full Text View

Purpose

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	Intervention	Phase
HIV Sexual Behavior Methamphetamine Behavioral Research	Behavioral: Contingency management	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention
Official Title:	Development of a Methamphetamine Early Intervention

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Metamfetamine

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

Non-concordant unprotected anal intercourse [ Time Frame: Baseline, 6, 12, 18, 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of non-concordant unprotected anal intercourse partners [ Time Frame: Baseline, 6, 12, 18, 24 weeks ] [ Designated as safety issue: No ]
Stimulant (methamphetamine and crack/cocaine) urinalyses [ Time Frame: Baseline, 6, 12, 18, 24 weeks ] [ Designated as safety issue: No ]
Self-reported methamphetamine use [ Time Frame: Baseline, 6, 12, 18, 24 weeks ] [ Designated as safety issue: No ]


Enrollment:	127
Study Start Date:	December 2006
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Referral to community resources
Experimental: Contingency Management	Behavioral: Contingency management A 12-week contingency management intervention Other Name: Voucher-based reinforcement

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174654

Locations


United States, Washington
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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	University of Washington
ClinicalTrials.gov Identifier:	NCT01174654 History of Changes
Other Study ID Numbers:	R21DA019420-01A1
Study First Received:	August 2, 2010
Last Updated:	December 12, 2012
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:


Methamphetamine Central Nervous System Stimulants Physiological Effects of Drugs Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Dopamine Agents	Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on September 30, 2016