NCT00111501

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
792

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2002

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 23, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

6.3 years

First QC Date

May 20, 2005

Last Update Submit

March 5, 2015

Conditions

Keywords

smokingtobacco

Outcome Measures

Primary Outcomes (1)

  • point-prevalence abstinence from tobacco use

    Self-report of smoking status during the past seven days.

    7-day

Study Arms (2)

Targeted Internet Intervention

EXPERIMENTAL

Web-based self help intervention developed to include specific cultural tailoring relevant to the LGBT community

Behavioral: Tobacco Use Disorder

Standard Intervention

ACTIVE COMPARATOR

Standard self-help internet-based intervention with no LGBT relevant information included

Behavioral: Standard Web-based intervention

Interventions

Web-based psychoeducational intervention culturally-tailored to the LGBT community including a social support component

Targeted Internet Intervention

General psychoeducational Web-based smoking cessation intervention

Standard Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco Medical Cen

San Francisco, California, 94143 0939, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderSmoking

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Study Officials

  • Gary Humfleet, Ph.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2005

First Posted

May 23, 2005

Study Start

September 1, 2002

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations