Tobacco UsePOPNCT03259360
A Facebook Intervention for Young Sexual and Gender Minority Smokers
A study testing POP: and TSP: in people with Tobacco Use and Smoking, run by University of California, San Francisco at 1 site in United States.
Trial summary
The 2-year research plan will test the Put It Out Project (POP) in a pilot randomized trial (N=120) compared to TSP and two historical control conditions. Participants will be young adults who smoke, identify as sexual or gender minorities, and use Facebook. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Smoking, Tobacco Dependence
- What is being tested?
- POP: and TSP:
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2018to 28 Feb 2020
- 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 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- read English
- between 18 and 25 years of age
- indicate they use Facebook "most" (≥ 4) days per week
- have smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week
- identifies as SGM
Who cannot join
- do not read English
- are not between 18 and 25 years of age
- indicate they do not use Facebook "most" (≥ 4) days per week
- have not smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week
- does not identify as SGM
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco Department of Psychiatry
San Francisco, California, 94143
About this study
The 2-year research plan will test the Put It Out Project (POP) in a pilot randomized trial (N=120) compared to TSP and two historical control conditions. Participants will be young adults who smoke, identify as sexual or gender minorities, and use Facebook. The primary outcome will be biochemically verified 7-day abstinence from smoking at 3 and 6 months. Secondary outcomes will be a quit attempt (y/n), stage of change, and thoughts about tobacco abstinence at 3 and 6 mos.
Read the detailed description
Participants will be randomized to one of two conditions: (1) a Facebook-delivered intervention addressing tobacco use, tailored to SGM young adults; or (2) a 3-month Facebook intervention targeting tobacco use. Both interventions will include 90 days of Facebook-based messages and activities tailored to participants' readiness to quit smoking.
Assessments will occur at baseline, 3, and 6 months follow-up. Assessments will include measures on smoking, thoughts about abstinence, and SGM identity experiences. All participants who report no past 7-day smoking will be asked to give biochemical verification of smoking status with saliva cotinine test kits that will be mailed to participants.
- Conditions
- Tobacco Use, Smoking, Tobacco Dependence, Tobacco Use Disorder, Tobacco Use Cessation, Tobacco Smoking
- Being tested
- POP:, TSP:
- Keywords
- Tobacco, Gender Identity Minority, Sexual Identity Minority, Cessation, Intervention, Young Adults, Social Media, Internet, Cigarette
- Medical subject headings
- Tobacco Use, Smoking, Tobacco Use Disorder, Tobacco Use Cessation, Tobacco Smoking, Smoking Cessation, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POP:Behavioural
90 days of Facebook messaging, weekly live sessions targeting tobacco use and tailored to sexual and gender minority young adults
TSP:Behavioural
90 days of Facebook messaging, weekly live sessions targeting tobacco use
| Study group | Role | What they receive |
|---|---|---|
| The Put It Out Project (POP): | Experimental | a culturally tailored intervention developed for SGM young adults on Facebook Receives: Behavioral: POP: |
| Tobacco Status Project (TSP): | Experimental | the original TSP intervention (non-tailored) delivered to groups of only SGM participants on Facebook Receives: Behavioral: TSP: |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence abstinence at 3 months
Reports of no smoking in the 7 days prior to the 3 month assessment. Biochemical verification of abstinence will also be recorded.
Measured: 3 months post baseline
7-day point prevalence abstinence at 6 months
Reports of no smoking in the 7 days prior to the 6 month assessment. Biochemical verification of abstinence will also be recorded.
Measured: 6 months post baseline
Secondary outcomes (4)
Reduction in cigarettes smoked by at least 50%
Reduction will be assessed at 3 and 6 month follow-ups.
Measured: 3 and 6 months post baseline
Tobacco use quit attempts
Whether a quit attempt was made during the follow-up period at 3 and 6 months post-baseline.
Measured: 3 and 6 months post baseline
Readiness to quit tobacco
Proportion of participants ready to quit smoking in the next month assessed at 3 and 6 months
Measured: 3 and 6 months post baseline
Thoughts About Tobacco Abstinence
Desire to quit, abstinence self-efficacy, perceived difficulty of quitting and abstinence goal
Measured: 3 and 6 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start23 Apr 2018
- Primary completion20 Apr 2019
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Tobacco UseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Gary L. Humfleet, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259360
- Sponsor's protocol ID
- PA-15-263
- Other IDs
- R21MD011765, K23DA032578
- Acronym
- POP
- Status last verified
- Jan 2025
- First submitted
- 21 Aug 2017
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramo DE, Thrul J, Chavez K, Delucchi KL, Prochaska JJ. Feasibility and Quit Rates of the Tobacco Status Project: A Facebook Smoking Cessation Intervention for Young Adults. J Med Internet Res. 2015 Dec 31;17(12):e291. doi: 10.2196/jmir.5209.
PubMed 26721211Thrul J, Klein AB, Ramo DE. Smoking Cessation Intervention on Facebook: Which Content Generates the Best Engagement? J Med Internet Res. 2015 Nov 11;17(11):e244. doi: 10.2196/jmir.4575.
PubMed 26561529Ramo DE, Thrul J, Delucchi KL, Ling PM, Hall SM, Prochaska JJ. The Tobacco Status Project (TSP): Study protocol for a randomized controlled trial of a Facebook smoking cessation intervention for young adults. BMC Public Health. 2015 Sep 15;15:897. doi: 10.1186/s12889-015-2217-0.
PubMed 26374203Ramo DE, Rodriguez TM, Chavez K, Sommer MJ, Prochaska JJ. Facebook Recruitment of Young Adult Smokers for a Cessation Trial: Methods, Metrics, and Lessons Learned. Internet Interv. 2014 Apr;1(2):58-64. doi: 10.1016/j.invent.2014.05.001.
PubMed 25045624Ramo DE, Liu H, Prochaska JJ. A mixed-methods study of young adults' receptivity to using Facebook for smoking cessation: if you build it, will they come? Am J Health Promot. 2015 Mar-Apr;29(4):e126-35. doi: 10.4278/ajhp.130326-QUAL-128. Epub 2014 Feb 27.
PubMed 24575728Vogel EA, Ramo DE, Meacham MC, Prochaska JJ, Delucchi KL, Humfleet GL. The Put It Out Project (POP) Facebook Intervention for Young Sexual and Gender Minority Smokers: Outcomes of a Pilot, Randomized, Controlled Trial. Nicotine Tob Res. 2020 Aug 24;22(9):1614-1621. doi: 10.1093/ntr/ntz184.
PubMed 31562765
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Facebook Intervention for Young Sexual and Gender Minority Smokers
- ClinicalTrials.gov ID
- NCT03259360
- Acronym / sponsor ID
- POP / PA-15-263
- Conditions
- Tobacco Use, Smoking, Tobacco Dependence, Tobacco Use Disorder, Tobacco Use Cessation, Tobacco Smoking
- Keywords
- Tobacco, Gender Identity Minority, Sexual Identity Minority, Cessation, Intervention, Young Adults, Social Media, Internet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), National Institute on Drug Abuse (NIDA)
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 20 Apr 2019 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 23 Aug 2017 (actual)
- 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 2-year research plan will test the Put It Out Project (POP) in a pilot randomized trial (N=120) compared to TSP and two historical control conditions. Participants will be young adults who smoke, identify as sexual or gender minorities, and use Facebook. The primary outcome will be biochemically verified 7-day abstinence from smoking at 3 and 6 months. Secondary outcomes will be a quit attempt (y/n), stage of change, and thoughts about tobacco abstinence at 3 and 6 mos.
Detailed description
Participants will be randomized to one of two conditions: (1) a Facebook-delivered intervention addressing tobacco use, tailored to SGM young adults; or (2) a 3-month Facebook intervention targeting tobacco use. Both interventions will include 90 days of Facebook-based messages and activities tailored to participants' readiness to quit smoking.
Assessments will occur at baseline, 3, and 6 months follow-up. Assessments will include measures on smoking, thoughts about abstinence, and SGM identity experiences. All participants who report no past 7-day smoking will be asked to give biochemical verification of smoking status with saliva cotinine test kits that will be mailed to participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Put It Out Project (POP): | Experimental | Behavioral: POP:a culturally tailored intervention developed for SGM young adults on Facebook |
| Tobacco Status Project (TSP): | Experimental | Behavioral: TSP:the original TSP intervention (non-tailored) delivered to groups of only SGM participants on Facebook |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- read English
- between 18 and 25 years of age
- indicate they use Facebook "most" (≥ 4) days per week
- have smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week
- identifies as SGM
Key exclusion criteria (5 listed)
- do not read English
- are not between 18 and 25 years of age
- indicate they do not use Facebook "most" (≥ 4) days per week
- have not smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week
- does not identify as SGM
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 |
|---|---|---|
| POP:90 days of Facebook messaging, weekly live sessions targeting tobacco use and tailored to sexual and gender minority young adults | Behavioural | The Put It Out Project (POP): |
| TSP:90 days of Facebook messaging, weekly live sessions targeting tobacco use | Behavioural | Tobacco Status Project (TSP): |
Primary outcome
7-day point prevalence abstinence at 3 months
Time frame: 3 months post baseline
Reports of no smoking in the 7 days prior to the 3 month assessment. Biochemical verification of abstinence will also be recorded.
7-day point prevalence abstinence at 6 months
Time frame: 6 months post baseline
Reports of no smoking in the 7 days prior to the 6 month assessment. Biochemical verification of abstinence will also be recorded.
4 secondary outcomes
Reduction in cigarettes smoked by at least 50%
Time frame: 3 and 6 months post baseline
Tobacco use quit attempts
Time frame: 3 and 6 months post baseline
Readiness to quit tobacco
Time frame: 3 and 6 months post baseline
Thoughts About Tobacco Abstinence
Time frame: 3 and 6 months post baseline
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 Jan 2025.
- Background: PubMed 26721211Ramo DE, Thrul J, Chavez K, Delucchi KL, Prochaska JJ. Feasibility and Quit Rates of the Tobacco Status Project: A Facebook Smoking Cessation Intervention for Young Adults. J Med Internet Res. 2015 Dec 31;17(12):e291. doi: 10.2196/jmir.5209.
- Background: PubMed 26561529Thrul J, Klein AB, Ramo DE. Smoking Cessation Intervention on Facebook: Which Content Generates the Best Engagement? J Med Internet Res. 2015 Nov 11;17(11):e244. doi: 10.2196/jmir.4575.
- Background: PubMed 26374203Ramo DE, Thrul J, Delucchi KL, Ling PM, Hall SM, Prochaska JJ. The Tobacco Status Project (TSP): Study protocol for a randomized controlled trial of a Facebook smoking cessation intervention for young adults. BMC Public Health. 2015 Sep 15;15:897. doi: 10.1186/s12889-015-2217-0.
- Background: PubMed 25045624Ramo DE, Rodriguez TM, Chavez K, Sommer MJ, Prochaska JJ. Facebook Recruitment of Young Adult Smokers for a Cessation Trial: Methods, Metrics, and Lessons Learned. Internet Interv. 2014 Apr;1(2):58-64. doi: 10.1016/j.invent.2014.05.001.
- Background: PubMed 24575728Ramo DE, Liu H, Prochaska JJ. A mixed-methods study of young adults' receptivity to using Facebook for smoking cessation: if you build it, will they come? Am J Health Promot. 2015 Mar-Apr;29(4):e126-35. doi: 10.4278/ajhp.130326-QUAL-128. Epub 2014 Feb 27.
- Background: PubMed 31562765Vogel EA, Ramo DE, Meacham MC, Prochaska JJ, Delucchi KL, Humfleet GL. The Put It Out Project (POP) Facebook Intervention for Young Sexual and Gender Minority Smokers: Outcomes of a Pilot, Randomized, Controlled Trial. Nicotine Tob Res. 2020 Aug 24;22(9):1614-1621. doi: 10.1093/ntr/ntz184.
- 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.
Gary L. Humfleet, PhD 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 study testing POP: and TSP: in people with Tobacco Use and 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 5 inclusion and 5 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 Jan 2025. 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.
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?
7-day point prevalence abstinence at 3 months (time frame: 3 months post baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03259360, which also lists 6 linked publications.
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 Jan 2025.