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Behavioral Therapy Development for Methamphetamine Abuse

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00252434
First received: November 10, 2005
Last updated: March 7, 2006
Last verified: August 2005
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Behavioral Therapy Development for Methamphetamine Abuse

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252434

Contacts
Contact: Jim A. Peck, PsyD. (310) 312-0500 ext 374 jpeck@mednet.ucla.edu

Locations
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         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Jim A. Peck, PsyD. UCLA Integrated Substance Abuse Programs
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00252434     History of Changes
Other Study ID Numbers: 1 R21 DA 018075
Study First Received: November 10, 2005
Last Updated: March 7, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
high-risk sexual behavior
methamphetamine use
drug craving
addiction behaviors

Additional relevant MeSH terms:
Depression
Sexually Transmitted Diseases
Behavioral Symptoms
Genital Diseases, Female
Genital Diseases, Male
Infection
Virus Diseases
Methamphetamine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Autonomic Agents
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014