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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00344214 |
This study will evaluate the effectiveness of a sexual risk reduction intervention in reducing sexual risk behavior in HIV uninfected, heterosexual people who use methamphetamine.
Condition | Intervention | Phase |
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Substance-Related Disorders HIV Infections Sexually Transmitted Diseases |
Behavioral: Tri-focal cognitive behavioral therapy - social skills training (CBTSS) counseling program Behavioral: Standard care |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Reducing HIV/STD Risk, Methamphetamine Use, and Depression Among Heterosexuals |
Estimated Enrollment: | 400 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive the tri-focal cognitive behavioral therapy - social skills training counseling program
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Behavioral: Tri-focal cognitive behavioral therapy - social skills training (CBTSS) counseling program
This condition is a Theory-Based Counseling Program. The program will involve nine 90-minute face-to-face counseling sessions that use CBT and strategies associated with social cognitive theory. The theory addresses three treatment domains, including mood regulation, reduction/cessation of meth use, and reduction of high risk sexual practices.
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2: Active Comparator
Participants will receive the standard care comparison condition
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Behavioral: Standard care
Standard care involves nine weekly, face-to-face individual counseling sessions that provide standard care in relation to sexual risk, methamphetamine use, and depression. The sexual risk component is a modified version of Project RESPECT 1 (CDC, Atlanta) that focuses on educational materials and personal risk appraisal. The meth component is a modified version of the 12-step drug abstinence program developed by the National Institute of Alcohol Abuse and Alcoholism (NIAAA) (Project MATCH). The depression component is an educational approach based primarily on materials provided by the National Alliance on Mental Illness (NAMI) and the National Institute of Mental Health (NIMH).
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Methamphetamine is an addictive stimulant drug that strongly activates certain systems in the brain and can cause strong feelings of euphoria. Methamphetamine use has been associated with high risk sexual practices, such as unprotected anal and vaginal sex, multiple sex partners, and sex with partners who inject drugs. These behaviors and others have led to higher rates of STD- and HIV-infections among methamphetamine users. Despite the connection between methamphetamine use and high risk sexual behaviors, few efforts have been made to develop and implement sexual risk reduction programs for this population. Studies of risk reduction programs for "at risk" populations have shown that longer programs are more effective in maintaining improvements in sexual risk behaviors. This study will evaluate the effectiveness of a long-term sexual risk reduction intervention in reducing sexual risk behavior among heterosexual, HIV uninfected people who use methamphetamine.
Participants in this 12-month, open-label study will be randomly assigned to one of the following two conditions: 1) "Tri-focal Cognitive Behavioral Therapy - Social Skills Training (CBTSS) Counseling Program." This condition represents the active experimental condition. Consistent with the theoretical framework, this condition will involve nine 90-minute face-to-face counseling sessions that use cognitive behavioral therapy and strategies associated with social cognitive theory and the theory or reasoned action to address three treatment domains—mood regulation, reduction/cessation of meth use, and reduction of high risk sexual practices. 2) "Standard Care Comparison Condition." Subjects who are assigned to this condition will participate in nine weekly, face-to-face individual counseling sessions that provide standard care in relation to sexual risk, methamphetamine use, and depression. The sexual risk component is a modified version of Project RESPECT (CDC, Atlanta)1 that focuses on educational materials and personal risk appraisal. The meth component is a modified version of the 12-step drug abstinence program developed by the National Institute of Alcohol Abuse and Alcoholism (NIAAA)(Project MATCH). The depression component is an educational approach based primarily on materials provided by the National Alliance on Mental Illness (NAMI) and the National Institute of Mental Health (NIMH). All three programs are widely available and used in community practice.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jim Zians, PhD | 619-543-5086 | jzians@ucsd.edu |
United States, California | |
HIV Neurobehavioral Research Center | Recruiting |
San Diego, California, United States, 92103 | |
Contact: Jim Zians, PhD 619-543-5086 jzians@ucsd.edu |
Principal Investigator: | Thomas L. Patterson, PhD | University of California, San Diego |
Responsible Party: | University of California, San Diego ( Thomas L. Patterson, Professor of Psychiatry ) |
Study ID Numbers: | R01 MH61146, DAHBR 9A-ASPQ |
Study First Received: | June 23, 2006 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00344214 |
Health Authority: | United States: Federal Government |
HIV STDs Methamphetamine |
Sexually Transmitted Diseases, Viral Depression Acquired Immunodeficiency Syndrome Disorders of Environmental Origin Depressive Disorder Genital Diseases, Male Immunologic Deficiency Syndromes Virus Diseases Genital Diseases, Female |
Methamphetamine Dopamine Mental Disorders HIV Infections Sexually Transmitted Diseases Substance-Related Disorders Amphetamine Retroviridae Infections Ethanol |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors RNA Virus Infections Neurotransmitter Agents Slow Virus Diseases Adrenergic Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Sympathomimetics |
Physiological Effects of Drugs Central Nervous System Stimulants Infection Pharmacologic Actions Autonomic Agents Therapeutic Uses Lentivirus Infections Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |