Cigarette SmokingPhase 2/3NCT00634218
Reaching and Treating Lesbian, Gay, Bisexual, and Transgender (LGBT) Cigarette Smokers
A Phase 2/3 study testing Mail-based Self-help plus Internet-based Smoking Treatment, Self-Help Manual plus Telephone counseling and Self-Help Manual in people with Cigarette Smoking, run by University of California, San Francisco at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Mail-based Self-help plus Internet-based Smoking Treatment, Self-Help Manual plus Telephone counseling and Self-Help Manual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 363 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jan 2012
- Phase
- Phase 2/3
- 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
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Univeristy of California, San Francisco
San Francisco, California, 94143
About this study
Official title: REaching and Treating LGBT Smokers: The Internet
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.
- Conditions
- Cigarette Smoking
- Being tested
- Mail-based Self-help plus Internet-based Smoking Treatment, Self-Help Manual plus Telephone counseling, Self-Help Manual, Self-Help Manual plus Internet-based Intervention plus Telephone Counseling
- Keywords
- nicotine, smoking, smoking cessation
- Medical subject headings
- Cigarette Smoking, Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mail-based Self-help plus Internet-based Smoking TreatmentBehavioural
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 counselingBehavioural
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 ManualBehavioural
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 CounselingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Mail-based Self Help (MSH) treatment. Participants will receive the self-help manual developed specifically for LGBT smokers. Receives: Behavioral: Self-Help Manual |
| 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. Receives: Behavioral: Mail-based Self-help plus Internet-based Smoking Treatment |
| 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. Receives: Behavioral: Self-Help Manual plus Telephone counseling |
| 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. Receives: Behavioral: Self-Help Manual plus Internet-based Intervention plus Telephone Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking status
Measured: 3,6, and 12 months following enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Responsible party
- Principal investigator, Gary Humfleet, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634218
- Sponsor's protocol ID
- TRDRP 15RT-0165
- Status last verified
- Jun 2012
- First submitted
- 4 Mar 2008
- Last updated
- 27 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REaching and Treating LGBT Smokers: The Internet
- ClinicalTrials.gov ID
- NCT00634218
- Acronym / sponsor ID
- TRDRP 15RT-0165
- Conditions
- Cigarette Smoking
- Keywords
- nicotine, smoking, smoking cessation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Study start
- Feb 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 12 Mar 2008 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Self-Help ManualMail-based Self Help (MSH) treatment. Participants will receive the self-help manual developed specifically for LGBT smokers. |
| 2 | Active comparator | Behavioral: Mail-based Self-help plus Internet-based Smoking TreatmentMail-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. |
| 3 | Active comparator | Behavioral: Self-Help Manual plus Telephone counselingMail-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. |
| 4 | Active comparator | Behavioral: Self-Help Manual plus Internet-based Intervention plus Telephone CounselingMail-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age
- identify as lesbian, gay, bisexual, or transgender
- access to the internet
- valid email account
- valid telephone number
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Mail-based Self-help plus Internet-based Smoking TreatmentParticipants 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. | Behavioural | 2 |
| Self-Help Manual plus Telephone counselingParticipants 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. | Behavioural | 3 |
| Self-Help ManualParticipants 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. | Behavioural | 1 |
| Self-Help Manual plus Internet-based Intervention plus Telephone CounselingParticipants 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 | Behavioural | 4 |
Primary outcome
Smoking status
Time frame: 3,6, and 12 months following enrollment.
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 27 Jun 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mail-based Self-help plus Internet-based Smoking Treatment, Self-Help Manual plus Telephone counseling and Self-Help Manual in people with Cigarette Smoking, 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?
The sponsor lists 7 inclusion and 1 exclusion criteria. 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 27 Jun 2012. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Smoking status (time frame: 3,6, and 12 months following enrollment.). 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 27 Jun 2012.