Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers (POP-6)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03553992
Recruitment Status : Active, not recruiting
First Posted : June 12, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Tobacco Related Disease Research Program
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Tobacco Use Smoking Tobacco Dependence Tobacco Use Disorder Tobacco Use Cessation Tobacco Smoking Smoking Cessation Smoking, Cigarette Smoking, Tobacco Behavioral: POP-6: Behavioral: TSP-6: Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers
Actual Study Start Date : October 29, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: The Put It Out Project (POP-6):
a culturally tailored intervention developed for sexual and gender minority (SGM) young adults on Facebook
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


Experimental: Tobacco Status Project (TSP-6):
the original TSP intervention (non-tailored) delivered to groups of only SGM participants on Facebook
Behavioral: TSP-6:

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

Drug: nicotine patch 14-day supply of nicotine patch





Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553992


Locations
Layout table for location information
United States, California
University of California San Francisco Department of Psychiatry
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Tobacco Related Disease Research Program
Investigators
Layout table for investigator information
Principal Investigator: Gary L. Humfleet, PhD University of California, San Francisco

Publications:
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03553992     History of Changes
Other Study ID Numbers: P0520362
26IR-0004 ( Other Grant/Funding Number: UC Tobacco-Related Disease Research Pgm )
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:
Tobacco
Gender Identity Minority
Sexual Identity Minority
Cessation
Intervention
Young Adults
Social Media
Internet
Cigarette

Additional relevant MeSH terms:
Layout table for MeSH terms
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders