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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00111501
Other study ID # NIDA-15791-1
Secondary ID R01DA015791R01-1
Status Completed
Phase Phase 3
First received May 20, 2005
Last updated March 5, 2015
Start date September 2002
Est. completion date January 2009

Study information

Verified date March 2015
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The overall goals of this line of research are to develop and evaluate innovative treatments for lesbian, gay, bisexual, and transgender (LGBT) cigarette smokers and to understand the processes related to smoking and relapse in this previously unstudied population of smokers. In this study, participants are randomly assigned to one of two Internet-based smoking cessation treatments: 1) a self-help intervention tailored LGBT smokers plus social support plus email-based counseling, or 2) a standard self-help condition alone, similar to other general smoking cessation treatments. Before starting the program, participants will complete measures of smoking, nicotine dependence, depression diagnosis, demographics, mood, motivation to change, and alcohol use. Smoking status will be determined at 1, 3, 6, and 12 months following the start of treatment. Data will be analyzed to compare the quit rates of the two Internet-based treatment groups. Also, we will complete exploratory analyses to determine those variables that best predict quitting for LGBT smokers.


Recruitment information / eligibility

Status Completed
Enrollment 792
Est. completion date January 2009
Est. primary completion date January 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Must identify as a lesbian, gay male, bisexual male or female or a transgender individual. Must smoke most days during the preceding month. Must have a valid email address.

Study Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
Tobacco Use Disorder
Web-based psychoeducational intervention culturally-tailored to the LGBT community including a social support component
Standard Web-based intervention
General psychoeducational Web-based smoking cessation intervention

Locations

Country Name City State
United States University of California San Francisco Medical Cen San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary point-prevalence abstinence from tobacco use Self-report of smoking status during the past seven days. 7-day No
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