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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03553992
Other study ID # P0520362
Secondary ID 26IR-0004
Status Completed
Phase N/A
First received
Last updated
Start date October 29, 2018
Est. completion date July 7, 2019

Study information

Verified date October 2020
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 173
Est. completion date July 7, 2019
Est. primary completion date July 7, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Intervention

Behavioral:
POP-6:
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:
90 days of Facebook messaging, weekly live sessions targeting tobacco use Drug: nicotine patch 14-day supply of nicotine patch

Locations

Country Name City State
United States University of California San Francisco Department of Psychiatry San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco Tobacco Related Disease Research Program

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 months post baseline
Primary 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. 6 months post baseline
Secondary Reduction in cigarettes smoked by at least 50% Reduction will be assessed at 3 and 6 month follow-ups 3 and 6 months post baseline
Secondary 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. 3 and 6 months post baseline
Secondary Readiness to quit tobacco Proportion of participants ready to quit smoking in the next month assessed at 3 and 6 months. 3 and 6 months post baseline
Secondary 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. 3 and 6 months post baseline
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