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Tobacco UsePOP-6NCT03553992

An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers

A study testing POP-6: and TSP-6: in people with Tobacco Use and Smoking, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The 2-year research plan will test the Extended Put It Out Project (POP-6) in a pilot randomized trial (N=168) compared to TSP-6, as well as comparing POP-6 and TSP-6 to the POP-3 and TSP-3 interventions from a previously-conducted trial. 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-6: and TSP-6:
Could I receive a placebo?
No, everyone receives an active treatment
How many people
173 participants
Where
1 siteUnited States
Study dates
29 Oct 2018to 7 Jul 2019
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
  • lives in California

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
  • does not live in California

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California San Francisco Department of Psychiatry

    San Francisco, California, 94143

Other trials in United States

About this study

The 2-year research plan will test the Extended Put It Out Project (POP-6) in a pilot randomized trial (N=168) compared to TSP-6, as well as comparing POP-6 and TSP-6 to the POP-3 and TSP-3 interventions from a previously-conducted trial. Participants will be young adults who smoke, identify as sexual or gender minorities (SGM), and use Facebook. 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 months.

Read the detailed description

Participants will be randomized to one of two conditions: (1) a 6-month Facebook-delivered intervention addressing tobacco use, tailored to SGM young adults; or (2) a 6-month Facebook intervention targeting tobacco use. Both interventions will include 180 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 nicotine test kits that will be mailed to participants.

Being tested
POP-6:, TSP-6:
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-6:Behavioural

    90 days of Facebook messaging, weekly live sessions targeting tobacco use and tailored to SGM young adults

    Drug: nicotine patch 14-day supply of nicotine patch

  • TSP-6:Behavioural

    90 days of Facebook messaging, weekly live sessions targeting tobacco use

    Drug: nicotine patch 14-day supply of nicotine patch

Study groups in NCT03553992
Study groupRoleWhat they receive
The Put It Out Project (POP-6):Experimentala culturally tailored intervention developed for sexual and gender minority (SGM) young adults on Facebook
Receives: Behavioral: POP-6:
Tobacco Status Project (TSP-6):Experimentalthe original TSP intervention (non-tailored) delivered to groups of only SGM participants on Facebook
Receives: Behavioral: TSP-6:

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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)

  1. 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

  2. Tobacco use quit attempts

    A Smoking Questionnaire will assess the presence and number of 24 hr quit attempts since the last assessment, used to calculate presence of at least one quit attempt (y/n) in the assessment time period. This questionnaire has good internal consistency and construct validity, and is routinely used in smoking treatment research.

    Measured: 3 and 6 months post baseline

  3. 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

  4. Thoughts About Tobacco Abstinence

    The 4-item Thoughts About Abstinence Form, will measure thoughts about abstinence (desire to quit, abstinence self-efficacy, and perceived difficulty of quitting) on a scale from 1 ("least") to 10("most"), and abstinence goal as no goal, intermediary goal (e.g., reduced smoking), or total abstinence.

    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.

  1. First posted12 Jun 2018
  2. Study start29 Oct 2018
  3. Primary completion7 Jul 2019
  4. Study completion7 Jul 2019

Resources

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
173 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03553992
Sponsor's protocol ID
P0520362
Other IDs
26IR-0004
Acronym
POP-6
Status last verified
Oct 2020
First submitted
30 May 2018
Last updated
19 Oct 2020
Results posted
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 26721211

  • Thrul 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 26561529

  • Ramo 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 26374203

  • Ramo 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 25045624

  • Ramo 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 24575728

Questions about this trial

What is this clinical trial studying?

A study testing POP-6: and TSP-6: 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 6 inclusion and 6 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 19 Oct 2020. 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 NCT03553992, which also lists 5 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 19 Oct 2020.

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