- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00111501
LGBT Internet Based Smoking Treatment - 1
March 5, 2015 updated by: University of California, San Francisco
LGBT Internet Based Smoking Treatment
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
792
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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San Francisco, California, United States, 94143 0939
- University of California San Francisco Medical Cen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Targeted Internet Intervention
Web-based self help intervention developed to include specific cultural tailoring relevant to the LGBT community
|
Web-based psychoeducational intervention culturally-tailored to the LGBT community including a social support component
|
Active Comparator: Standard Intervention
Standard self-help internet-based intervention with no LGBT relevant information included
|
General psychoeducational Web-based smoking cessation intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
point-prevalence abstinence from tobacco use
Time Frame: 7-day
|
Self-report of smoking status during the past seven days.
|
7-day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Gary Humfleet, Ph.D., University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2002
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
May 20, 2005
First Submitted That Met QC Criteria
May 20, 2005
First Posted (Estimate)
May 23, 2005
Study Record Updates
Last Update Posted (Estimate)
March 6, 2015
Last Update Submitted That Met QC Criteria
March 5, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIDA-15791-1
- R01DA015791 (U.S. NIH Grant/Contract)
- R01-15791-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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