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Completed

NCT Number: NCT03553992

An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers

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.

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Key information

Conditions

Tobacco Use Behavior Chemically-Induced Disorders Cigarette Smoking Health Behavior Mental Disorders Smoking Smoking Cessation Smoking, Cigarette Smoking, Tobacco Substance-Related Disorders Tobacco Dependence Tobacco Smoking Tobacco Use Cessation Tobacco Use Disorder

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco Department of Psychiatry

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

POP-6:

Behavioral

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:

Behavioral

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

Drug: nicotine patch 14-day supply of nicotine patch

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Reduction in cigarettes smoked by at least 50%

    Time frame: 3 and 6 months post baseline

    Reduction will be assessed at 3 and 6 month follow-ups

  2. Tobacco use quit attempts

    Time frame: 3 and 6 months post baseline

    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. Readiness to quit tobacco

    Time frame: 3 and 6 months post baseline

    Proportion of participants ready to quit smoking in the next month assessed at 3 and 6 months.

  4. Thoughts About Tobacco Abstinence

    Time frame: 3 and 6 months post baseline

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Tobacco Related Disease Research Program

Registry information

Acronym: POP-6

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 12, 2018
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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