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Behavioral Therapy Development for Methamphetamine Abuse

Primary Purpose

Depression, Drug Abuse, Sexually Transmitted Diseases

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy Development for Methamphetamine Abuse
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring high-risk sexual behavior, methamphetamine use, drug craving, addiction behaviors

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)Male

Inclusion Criteria: 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 Willing to give informed consent and comply with study procedures Willing to provide consent to contact treating physicians and pharmacies to assess adherence to HIV medications Diagnosed with current methamphetamine abuse as determined by Mini-International Neuropsychiatric Interview (MINI) Interested in seeking treatment for methamphetamine abuse and in participating in this research project. Exclusion Criteria: Unwilling to give, or withdrawal of, informed consent Inability to understand nature of study 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) Current suicidal ideation or suicide attempt within the past 3 months Concurrent dependence on opiates, alcohol, or benzodiazepines as determined by MINI. Total lack of any type of healthcare coverage. These potential participants will be given low-fee treatment referrals.

Sites / Locations

  • UCLA Center for Clinical AIDS Research and Education (CARE) Clinic

Outcomes

Primary Outcome Measures

methamphetamine use

Secondary Outcome Measures

sexual risk behaviors

Full Information

First Posted
November 10, 2005
Last Updated
January 26, 2016
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT00252434
Brief Title
Behavioral Therapy Development for Methamphetamine Abuse
Official Title
Behavioral Therapy Development for Methamphetamine Abuse
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
August 2004 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Drug Abuse, Sexually Transmitted Diseases
Keywords
high-risk sexual behavior, methamphetamine use, drug craving, addiction behaviors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy Development for Methamphetamine Abuse
Primary Outcome Measure Information:
Title
methamphetamine use
Time Frame
weekly
Secondary Outcome Measure Information:
Title
sexual risk behaviors
Time Frame
monthly

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Eligibility Criteria
Inclusion Criteria: 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 Willing to give informed consent and comply with study procedures Willing to provide consent to contact treating physicians and pharmacies to assess adherence to HIV medications Diagnosed with current methamphetamine abuse as determined by Mini-International Neuropsychiatric Interview (MINI) Interested in seeking treatment for methamphetamine abuse and in participating in this research project. Exclusion Criteria: Unwilling to give, or withdrawal of, informed consent Inability to understand nature of study 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) Current suicidal ideation or suicide attempt within the past 3 months Concurrent dependence on opiates, alcohol, or benzodiazepines as determined by MINI. Total lack of any type of healthcare coverage. These potential participants will be given low-fee treatment referrals.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James A. Peck, PsyD.
Organizational Affiliation
UCLA Integrated Substance Abuse Programs
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James A Peck, Psy.D.
Organizational Affiliation
UCLA Integrated Substance Abuse Programs
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Center for Clinical AIDS Research and Education (CARE) Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90035
Country
United States

12. IPD Sharing Statement

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Behavioral Therapy Development for Methamphetamine Abuse

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