Behavioral Therapy Development for Methamphetamine Abuse

Depression Clinical Trial

Official title:

Behavioral Therapy Development for Methamphetamine Abuse

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00252434
• Other study ID #: 1R21DA018075
• Status: Terminated
• Phase: Phase 1
• First received: November 10, 2005
• Last updated: January 26, 2016
• Start date: August 2004
• Est. completion date: November 2007

Study information

• Verified date: January 2016
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Drug Abuse
• Sexually Transmitted Diseases

Intervention

Behavioral:
• Cognitive Behavioral Therapy Development for Methamphetamine Abuse

Locations

Country	Name	City	State
United States	UCLA Center for Clinical AIDS Research and Education (CARE) Clinic	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	methamphetamine use		weekly	No
Secondary	sexual risk behaviors		monthly	No