Tobacco Use DisorderPhase 3NCT00111501
LGBT Internet Based Smoking Treatment - 1
A Phase 3 study testing Tobacco Use Disorder and Standard Web-based intervention in people with Tobacco Use Disorder, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Tobacco Use Disorder and Standard Web-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 792 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Jan 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco Medical Cen
San Francisco, California, 94143 0939
About this study
Official title: 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.
- Conditions
- Tobacco Use Disorder
- Being tested
- Tobacco Use Disorder, Standard Web-based intervention
- Keywords
- smoking, tobacco
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco Use DisorderBehavioural
Web-based psychoeducational intervention culturally-tailored to the LGBT community including a social support component
Standard Web-based interventionBehavioural
General psychoeducational Web-based smoking cessation intervention
| Study group | Role | What they receive |
|---|---|---|
| Targeted Internet Intervention | Experimental | Web-based self help intervention developed to include specific cultural tailoring relevant to the LGBT community Receives: Behavioral: Tobacco Use Disorder |
| Standard Intervention | Active comparator | Standard self-help internet-based intervention with no LGBT relevant information included Receives: Behavioral: Standard Web-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
point-prevalence abstinence from tobacco use
Self-report of smoking status during the past seven days.
Measured: 7-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2005 (estimated)
- Study startSep 2002
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 792 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Gary Humfleet, Ph.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111501
- Sponsor's protocol ID
- NIDA-15791-1
- Other IDs
- R01DA015791, R01-15791-1
- Status last verified
- Mar 2015
- First submitted
- 20 May 2005
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LGBT Internet Based Smoking Treatment
- ClinicalTrials.gov ID
- NCT00111501
- Acronym / sponsor ID
- NIDA-15791-1
- Conditions
- Tobacco Use Disorder
- Keywords
- smoking, tobacco
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 792 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2002
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 23 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted Internet Intervention | Experimental | Behavioral: Tobacco Use DisorderWeb-based self help intervention developed to include specific cultural tailoring relevant to the LGBT community |
| Standard Intervention | Active comparator | Behavioral: Standard Web-based interventionStandard self-help internet-based intervention with no LGBT relevant information included |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tobacco Use DisorderWeb-based psychoeducational intervention culturally-tailored to the LGBT community including a social support component | Behavioural | Targeted Internet Intervention |
| Standard Web-based interventionGeneral psychoeducational Web-based smoking cessation intervention | Behavioural | Standard Intervention |
Primary outcome
point-prevalence abstinence from tobacco use
Time frame: 7-day
Self-report of smoking status during the past seven days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Humfleet, Ph.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tobacco Use Disorder and Standard Web-based intervention in people with Tobacco Use Disorder, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
point-prevalence abstinence from tobacco use (time frame: 7-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.