Smoking CessationNCT03002883
STAND Community College Tobacco Cessation Trial
A study testing Brief Motivational Interviewing and Direct referral to quitline in people with Smoking Cessation, run by University of California, Davis.
Trial summary
Community colleges have 45% of the nation's undergraduates and have a higher smoking prevalence rate than 4-year colleges. California's community colleges comprise the nation's largest higher education system, and Sacramento has the second largest community college district. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Brief Motivational Interviewing and Direct referral to quitline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Jun 2016
- Phase
- Interventional
- 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
- adult 18 years or older
- current smoker in the past 30 days
- smoker wants to quit
- smoker not currently participating in other smoking cessation activities, and
- smoker must be willing to accept randomization into any of the 3 study arms
Who cannot join
- students not proficient in communicating in English
- adults unable to consent
About this study
Official title: Sacramento Taking Action Against Nicotine Dependence (STAND) at Sacramento City College
Community colleges have 45% of the nation's undergraduates and have a higher smoking prevalence rate than 4-year colleges. California's community colleges comprise the nation's largest higher education system, and Sacramento has the second largest community college district. As more colleges are encouraged to become smoke and tobacco-free campuses, smokers enrolled at community college campuses need greater support. However, community colleges may lack the student health clinic resources that 4-year colleges have for students who live on campus. Little evidence to date demonstrates effective interventions for smokers on community college campuses.
This pilot study seeks to demonstrate the feasibility and promising outcomes of two cessation interventions, compared with usual care on a community college campus. The first intervention was based on a promising model of brief motivational interviewing delivered by peer educators, developed by the community lead Breathe California of Sacramento-Emigrant Trails (BCSET) through the Sacramento Taking Action Against Tobacco Dependence (STAND) project. The second intervention was based on direct enrollment into the California Smokers' Helpline, which has demonstrated utility for promoting smoking cessation among young adults with low socioeconomic status. Usual care consisted of students going to the student health center for smoking cessation assistance.
- Conditions
- Smoking Cessation
- Being tested
- Usual Care, Brief Motivational Interviewing, Direct referral to quitline
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareBehavioural
Participant provided "Quit Kit" water bottle with small cessation aids (eg. sunflower seeds) and educated about student health as a cessation resource
Brief Motivational InterviewingBehavioural
Peer educator conducts brief motivational interviewing about smoking cessation and participant goals
Direct referral to quitlineBehavioural
Peer educator educates about state quitline services and gets verbal consent to use quitline's direct referral web portal for quitline to contact participant in 1-2 business days about free counseling services to make a quit plan
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Placebo comparator | Students referred to student health for tobacco cessation resources including campus "Quit Kits" Receives: Behavioral: Usual Care |
| Brief Motivational Interviewing | Active comparator | Students received brief motivational interviewing by a student peer educator about tobacco cessation Receives: Behavioral: Usual Care; Behavioral: Brief Motivational Interviewing |
| Direct referral to quitline | Active comparator | Students were directly referred to the state quitline for follow-up counseling Receives: Behavioral: Usual Care; Behavioral: Direct referral to quitline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically validated smoking cessation
Point prevalence abstinence validated by saliva cotinine level
Measured: 6 months
Secondary outcomes (3)
Self-reported smoking cessation
Point prevalence abstinence by self-report on survey
Measured: 6 months
Self-reported smoking cessation
Point prevalence abstinence by self-report on survey
Measured: 3 months
Self-reported smoking cessation
Point prevalence abstinence by self-report on survey
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study startSep 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Tobacco Related Disease Research Program, Breathe California of Sacramento-Emigrant Trails, Sacramento City College
- Responsible party
- Sponsor
- Investigators
- Elisa Tong, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002883
- Sponsor's protocol ID
- 491744
- Other IDs
- 22BT-0057
- Status last verified
- Mar 2017
- First submitted
- 19 Dec 2016
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacramento Taking Action Against Nicotine Dependence (STAND) at Sacramento City College
- ClinicalTrials.gov ID
- NCT03002883
- Acronym / sponsor ID
- 491744
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Tobacco Related Disease Research Program, Breathe California of Sacramento-Emigrant Trails, Sacramento City College
- Study start
- Sep 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 Dec 2016 (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.
Community colleges have 45% of the nation's undergraduates and have a higher smoking prevalence rate than 4-year colleges. California's community colleges comprise the nation's largest higher education system, and Sacramento has the second largest community college district. As more colleges are encouraged to become smoke and tobacco-free campuses, smokers enrolled at community college campuses need greater support. However, community colleges may lack the student health clinic resources that 4-year colleges have for students who live on campus. Little evidence to date demonstrates effective interventions for smokers on community college campuses.
This pilot study seeks to demonstrate the feasibility and promising outcomes of two cessation interventions, compared with usual care on a community college campus. The first intervention was based on a promising model of brief motivational interviewing delivered by peer educators, developed by the community lead Breathe California of Sacramento-Emigrant Trails (BCSET) through the Sacramento Taking Action Against Tobacco Dependence (STAND) project. The second intervention was based on direct enrollment into the California Smokers' Helpline, which has demonstrated utility for promoting smoking cessation among young adults with low socioeconomic status. Usual care consisted of students going to the student health center for smoking cessation assistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Placebo comparator | Behavioral: Usual CareStudents referred to student health for tobacco cessation resources including campus "Quit Kits" |
| Brief Motivational Interviewing | Active comparator | Behavioral: Usual Care, Behavioral: Brief Motivational InterviewingStudents received brief motivational interviewing by a student peer educator about tobacco cessation |
| Direct referral to quitline | Active comparator | Behavioral: Usual Care, Behavioral: Direct referral to quitlineStudents were directly referred to the state quitline for follow-up counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult 18 years or older
- current smoker in the past 30 days
- smoker wants to quit
- smoker not currently participating in other smoking cessation activities, and
- smoker must be willing to accept randomization into any of the 3 study arms
Key exclusion criteria (2 listed)
- students not proficient in communicating in English
- adults unable to consent
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 |
|---|---|---|
| Usual CareParticipant provided "Quit Kit" water bottle with small cessation aids (eg. sunflower seeds) and educated about student health as a cessation resource | Behavioural | Brief Motivational Interviewing, Direct referral to quitline, Usual Care |
| Brief Motivational InterviewingPeer educator conducts brief motivational interviewing about smoking cessation and participant goals | Behavioural | Brief Motivational Interviewing |
| Direct referral to quitlinePeer educator educates about state quitline services and gets verbal consent to use quitline's direct referral web portal for quitline to contact participant in 1-2 business days about free counseling services to make a quit plan | Behavioural | Direct referral to quitline |
Primary outcome
Biochemically validated smoking cessation
Time frame: 6 months
Point prevalence abstinence validated by saliva cotinine level
3 secondary outcomes
Self-reported smoking cessation
Time frame: 6 months
Self-reported smoking cessation
Time frame: 3 months
Self-reported smoking cessation
Time frame: 1 month
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 30 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Elisa Tong, MD principal investigator
University of California, Davis
Questions about this trial
What is this clinical trial studying?
A study testing Brief Motivational Interviewing and Direct referral to quitline in people with Smoking Cessation, run by University of California, Davis.
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 5 inclusion and 2 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 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Biochemically validated smoking cessation (time frame: 6 months). 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 30 Mar 2017.