Behavioral Therapy Development for Methamphetamine Abuse



Status:Terminated
Conditions:Depression, Infectious Disease, Psychiatric
Therapuetic Areas:Immunology / Infectious Diseases, Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:August 2004
End Date:November 2007

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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.

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.
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