Back to resultsLGBT Internet Based Smoking Treatment - 1
Primary Purpose
Tobacco Use Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tobacco Use Disorder
Standard Web-based intervention
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Use Disorder focused on measuring smoking, tobacco
Eligibility Criteria
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.
Sites / Locations
- University of California San Francisco Medical Cen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Targeted Internet Intervention
Standard Intervention
Arm Description
Web-based self help intervention developed to include specific cultural tailoring relevant to the LGBT community
Standard self-help internet-based intervention with no LGBT relevant information included
Outcomes
Primary Outcome Measures
point-prevalence abstinence from tobacco use
Self-report of smoking status during the past seven days.
Secondary Outcome Measures
Full Information
NCT ID
NCT00111501
First Posted
May 20, 2005
Last Updated
March 5, 2015
Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00111501
Brief Title
LGBT Internet Based Smoking Treatment - 1
Official Title
LGBT Internet Based Smoking Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
smoking, tobacco
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
792 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Targeted Internet Intervention
Arm Type
Experimental
Arm Description
Web-based self help intervention developed to include specific cultural tailoring relevant to the LGBT community
Arm Title
Standard Intervention
Arm Type
Active Comparator
Arm Description
Standard self-help internet-based intervention with no LGBT relevant information included
Intervention Type
Behavioral
Intervention Name(s)
Tobacco Use Disorder
Intervention Description
Web-based psychoeducational intervention culturally-tailored to the LGBT community including a social support component
Intervention Type
Behavioral
Intervention Name(s)
Standard Web-based intervention
Intervention Description
General psychoeducational Web-based smoking cessation intervention
Primary Outcome Measure Information:
Title
point-prevalence abstinence from tobacco use
Description
Self-report of smoking status during the past seven days.
Time Frame
7-day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Humfleet, Ph.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco Medical Cen
City
San Francisco
State/Province
California
ZIP/Postal Code
94143 0939
Country
United States
12. IPD Sharing Statement
Learn more about this trial
LGBT Internet Based Smoking Treatment - 1
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