Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252434
Status:
TERMINATED
Last Update Posted:
2016-01-27
First Post:
2005-11-10
Brief Title:
Behavioral Therapy Development for Methamphetamine Abuse
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Behavioral Therapy Development for Methamphetamine Abuse
Status:
TERMINATED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 HIVAIDS 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 clinics 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 inclusionexclusion 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None