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Behavioral Therapy Development for Methamphetamine Abuse
This study is currently recruiting participants.
Study NCT00252434   Information provided by University of California, Los Angeles
First Received: November 10, 2005   Last Updated: March 7, 2006   History of Changes

November 10, 2005
March 7, 2006
 
 
 
 
Complete list of historical versions of study NCT00252434 on ClinicalTrials.gov Archive Site
 
 
 
Behavioral Therapy Development for Methamphetamine Abuse
Behavioral Therapy Development for Methamphetamine Abuse

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.

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.

 
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment
  • Depression
  • Drug Abuse
  • Sexually Transmitted Diseases
Behavioral: Cognitive Behavioral Therapy Development for Methamphetamine Abuse
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
 
 
 

Inclusion Criteria:

  1. HIV-seropositive, GBM receiving medical treatment for HIV for at least 30 days prior to signing informed consent at the University of California, Los Angeles (UCLA) Center for Clinical AIDS Research and Education (CARE) clinic, aged 18-65
  2. Willing to give informed consent and comply with study procedures
  3. Willing to provide consent to contact treating physicians and pharmacies to assess adherence to HIV medications
  4. Diagnosed with current methamphetamine abuse as determined by Mini-International Neuropsychiatric Interview (MINI)
  5. Interested in seeking treatment for methamphetamine abuse and in participating in this research project.

Exclusion Criteria:

  1. Unwilling to give, or withdrawal of, informed consent
  2. Inability to understand nature of study
  3. A psychiatric condition that, in the principal investigator’s judgment, warrants additional intervention to ensure participant safety (e.g., meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision [DSM-IV-TR] criteria for current bipolar disorder or a psychotic disorder)
  4. Current suicidal ideation or suicide attempt within the past 3 months
  5. Concurrent dependence on opiates, alcohol, or benzodiazepines as determined by MINI.
  6. Total lack of any type of healthcare coverage. These potential participants will be given low-fee treatment referrals.
Male
18 Years to 65 Years
 
Contact: Jim A. Peck, PsyD. (310) 312-0500 ext 374 jpeck@mednet.ucla.edu
United States
 
NCT00252434
 
1 R21 DA 018075
University of California, Los Angeles
 
Principal Investigator: Jim A. Peck, PsyD. UCLA Integrated Substance Abuse Programs
University of California, Los Angeles
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP