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| Sponsored by: |
University of California, Los Angeles |
|---|---|
| Information provided by: | University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00252434 |
Purpose
The purpose of this study is to evaluate whether a specially developed group counseling approach is better able to help HIV-positive gay and bisexual men (GBM) who use crystal meth to stop using methamphetamines, reduce sexual risk behaviors, and stay on their HIV medications than a standard drug treatment program. Another purpose is to determine whether having a drug abuse treatment program in an HIV medical clinic makes it easier to attend treatment than going to a separate location for drug abuse treatment.
| Condition | Intervention |
|---|---|
|
Depression Drug Abuse Sexually Transmitted Diseases |
Behavioral: Cognitive Behavioral Therapy Development for Methamphetamine Abuse |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
| Official Title: | Behavioral Therapy Development for Methamphetamine Abuse |
The study features activities that include development and refinement of a culturally-specific cognitive behavioral therapy that integrates aspects of drug abuse treatment with HIV medication adherence interventions and cultural elements of being a gay or bisexual man receiving medical care for HIV/AIDS. To estimate the size of the signal of this intervention, the study proposes a two parallel group design in which 50 treatment-seeking HIV-seropositive gay and bisexual men who meet criteria for methamphetamine abuse and who receive HIV medical care at the UCLA Center for Clinical AIDS Research and Education (CARE) clinic are randomized to the study condition or a treatment-as-usual (TAU) condition. Participants assigned to the experimental condition receive 12 weeks of twice-weekly GCBT, with a 6-months post-randomization follow-up visit. Participants assigned to the TAU condition are referred to the UCLA Addiction Medicine Clinic (AMC), where they receive the clinic’s standard of care treatment for methamphetamine dependence for 12 weeks, and return for a 6-month follow-up visit. Analyses are conducted on all participants who meet inclusion/exclusion criteria, express desire for treatment, and receive at least one “dose” of the cognitive-behavioral treatment or make one visit to the AMC. Participants in both conditions agree to weekly and monthly data collection visits, including the provision of urine samples. Primary outcome variables are methamphetamine use, sexual risk behaviors, and HIV medication compliance. The proposed design maintains the focus on intervention development and feasibility, while recognizing that the second phase of this development will be informed by having accurate estimates of effect sizes for the intervention and adequate resources to conduct the full-scale trial.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Male |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jim A. Peck, PsyD. | (310) 312-0500 ext 374 | jpeck@mednet.ucla.edu |
| United States, California | |
| UCLA Center for Clinical AIDS Research and Education (CARE) Clinic | Recruiting |
| Los Angeles, California, United States, 90035 | |
| Principal Investigator: Ardis Moe, MD | |
| Principal Investigator: | Jim A. Peck, PsyD. | UCLA Integrated Substance Abuse Programs |
More Information
| Study ID Numbers: | 1 R21 DA 018075 |
| Study First Received: | November 10, 2005 |
| Last Updated: | March 7, 2006 |
| ClinicalTrials.gov Identifier: | NCT00252434 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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high-risk sexual behavior methamphetamine use drug craving addiction behaviors |
|
Dopamine Uptake Inhibitors Neurotransmitter Agents Behavior, Addictive Depression Adrenergic Agents Disorders of Environmental Origin Central Nervous System Stimulants Depressive Disorder Genital Diseases, Male Behavioral Symptoms |
Virus Diseases Genital Diseases, Female Methamphetamine Dopamine Mental Disorders Sexually Transmitted Diseases Substance-Related Disorders Dopamine Agents Amphetamine Peripheral Nervous System Agents |
|
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Physiological Effects of Drugs Disorders of Environmental Origin Infection Genital Diseases, Female Mental Disorders Therapeutic Uses Substance-Related Disorders Depression |
Sympathomimetics Central Nervous System Stimulants Genital Diseases, Male Pharmacologic Actions Behavioral Symptoms Virus Diseases Methamphetamine Autonomic Agents Sexually Transmitted Diseases Amphetamine Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |