ClinicalTrials.gov
ClinicalTrials.gov Menu

Development of a Methamphetamine Early Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01174654
Recruitment Status : Completed
First Posted : August 3, 2010
Last Update Posted : December 13, 2012
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Washington

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
HIV Sexual Behavior Methamphetamine Behavioral Research Behavioral: Contingency management Phase 1 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
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 : December 2006
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
No Intervention: Referral to community resources
Experimental: Contingency Management Behavioral: Contingency management
A 12-week contingency management intervention
Other Name: Voucher-based reinforcement


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Non-concordant unprotected anal intercourse [ Time Frame: Baseline, 6, 12, 18, 24 weeks ]

Secondary Outcome Measures :
  1. Number of non-concordant unprotected anal intercourse partners [ Time Frame: Baseline, 6, 12, 18, 24 weeks ]
  2. Stimulant (methamphetamine and crack/cocaine) urinalyses [ Time Frame: Baseline, 6, 12, 18, 24 weeks ]
  3. Self-reported methamphetamine use [ Time Frame: Baseline, 6, 12, 18, 24 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01174654     History of Changes
Other Study ID Numbers: R21DA019420-01A1 ( U.S. NIH Grant/Contract )
R21DA019420-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 3, 2010    Key Record Dates
Last Update Posted: December 13, 2012
Last Verified: December 2012

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