Reaching and Treating Lesbian, Gay, Bisexual, and Transgender (LGBT) Cigarette Smokers

Cigarette Smoking Clinical Trial

Official title:

REaching and Treating LGBT Smokers: The Internet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00634218
• Other study ID #: TRDRP 15RT-0165
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 4, 2008
• Last updated: June 25, 2012
• Start date: February 2008
• Est. completion date: January 2012

Study information

• Verified date: June 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

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

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

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.
• 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.
• 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.
• 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

Locations

Country	Name	City	State
United States	Univeristy of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Tobacco Related Disease Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking status		3,6, and 12 months following enrollment.	No