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Reaching and Treating Lesbian, Gay, Bisexual, and Transgender (LGBT) Cigarette Smokers
This study is currently recruiting participants.
Verified by University of California, San Francisco, March 2008
First Received: March 4, 2008   Last Updated: March 11, 2008   History of Changes
Sponsors and Collaborators: University of California, San Francisco
Calilfornia Tobacco Related Disease Research Program
Information provided by: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00634218
  Purpose

Smoking rates are significantly higher among lesbian, gay, bisexual, and transgender (LGBT) populations compared to the general population. LGBT individuals may be at increased risk for experiencing psychosocial issues, e.g., negative moods, stress, alcohol/drug use, that have been associated with smoking treatment failure in other groups of smokers. Technology, such as the Internet and telephone, can be an effective method to reach a large number of smokers and may be particularly effective in reaching hidden populations. Thus, the study seeks to examine whether Internet-based counseling and/or telephone counseling can improve quit rates for LGBT smokers. Participants (N=600) will be randomly assigned to one of four conditions: 1) a Mail-based Self Help (MSH) treatment; 2) MSH plus an Internet-based Smoking Treatment (IST); MSH plus Telephone Counseling (TC) or 4) MSH plus IST plus TC. Participants in the MSH condition will receive a self-help smoking cessation manual. In the IST condition, participants will receive the manual plus access to an Internet-based intervention that includes social support. In the TC condition, participants will receive the manual plus 6 telephone-based counseling sessions. In the fourth condition, participants will receive the manual plus access to an Internet-based intervention plus telephone counseling. Before starting treatment, participants will complete questionnaires on smoking, nicotine dependence, demographics, negative mood, and alcohol use. Participants will be contacted at 3, 6, and 12 months after enrollment to determine whether they are smoking. The data will be analyzed to compare the efficacy of the four treatments and to examine the possible influence of existing social networks and level of negative mood on treatment outcome and to examine the possible influence of residency (rural versus urban) on use of the Internet-based treatment.


Condition Intervention Phase
Cigarette Smoking
Behavioral: Mail-based Self-help plus Internet-based Smoking Treatment
Behavioral: Self-Help Manual plus Telephone counseling
Behavioral: Self-Help Manual
Behavioral: Self-Help Manual plus Internet-based Intervention plus Telephone Counseling
Phase II
Phase III

MedlinePlus related topics: Gay, Lesbian and Transgender Health Quitting Smoking Smoking
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Factorial Assignment
Official Title: REaching and Treating LGBT Smokers: The Internet

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Smoking status [ Time Frame: 3,6, and 12 months following enrollment. ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: February 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Mail-based Self Help (MSH) treatment. Participants will receive the self-help manual developed specifically for LGBT smokers.
Behavioral: Self-Help Manual
Participants will receive a self-help smoking cessation manual specifically developed for LGBT smokers. The manual provides information on quitting smoking and encourages the development of a personalized quit plan through various activities and exercises.
2: Active Comparator
Mail-based Self Help plus an Internet-based Smoking Treatment (IST). In the IST condition, participants will receive the manual plus access to an Internet-based intervention that includes social support.
Behavioral: Mail-based Self-help plus Internet-based Smoking Treatment
Participants in this condition will received a self-help manual developed specifically for LGBT smokers and access to an Internet-based smoking cessation treatment program. The website provides education and information about smoking cessation alond with development of a personalized quit plan. Participants have access to a message board where they can contact other participants.
3: Active Comparator
Mail-based Self-Help plus Telephone Counseling (TC). In the TC condition, participants will receive a self-help manual specifically developed for LGBT smokers plus 6 telephone-based counseling sessions.
Behavioral: Self-Help Manual plus Telephone counseling
Participants will receive a self-help manual specifically developed for LGBT smokers plus 6 telephone-based counseling sessions. The counseling sessions focus on the development of a personalized plan to quit smoking and occur over a 3 month period.
4: Active Comparator
Mail-based Self-Help plus an Internet-based Intervention plus Telephone Counseling. Participants will receive a self-help manual, have access to an internet-based smoking treatment and participante in 6 telephone counseling sessions.
Behavioral: Self-Help Manual plus Internet-based Intervention plus Telephone Counseling
Participants in this condition will received a self-help manual developed specifically for LGBT smokers and access to an Internet-based smoking cessation treatment program. The website provides education and information about smoking cessation alond with development of a personalized quit plan. Participants have access to a message board where they can contact other participants. Smokers will also receive 6 telephone-based counseling sessions which occur over a 3 month period

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years of age
  • identify as lesbian, gay, bisexual, or transgender
  • access to the internet
  • valid email account
  • valid telephone number
  • English speaking
  • resident of the U.S.

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00634218

Contacts
Contact: Gary L Humfleet, Ph.D. 415-476-7674 ghumfleet@lppi.ucsf.edu

Locations
United States, California
Univeristy of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Gary Humfleet, Ph.D.     415-476-7674     ghumfleet@lppi.ucsf.edu    
Principal Investigator: Gary L Humfleet, Ph.D.            
Sponsors and Collaborators
University of California, San Francisco
Calilfornia Tobacco Related Disease Research Program
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco ( Gary Humfleet, Ph.D., Associate Professor )
Study ID Numbers: TRDRP 15RT-0165
Study First Received: March 4, 2008
Last Updated: March 11, 2008
ClinicalTrials.gov Identifier: NCT00634218     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
nicotine
smoking
smoking cessation

Study placed in the following topic categories:
Nicotine polacrilex
Smoking
Nicotine

Additional relevant MeSH terms:
Habits
Smoking

ClinicalTrials.gov processed this record on May 07, 2009