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Social Media Intervention to Stop Nicotine and Cannabis Vaping Among Adolescents

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ClinicalTrials.gov Identifier: NCT04707911
Recruitment Status : Not yet recruiting
First Posted : January 13, 2021
Last Update Posted : May 25, 2021
Sponsor:
Collaborators:
Tobacco Related Disease Research Program
HopeLab Foundation
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
Social media based intervention to support teens in their efforts to quit vaping.

Condition or disease Intervention/treatment Phase
Vaping Behavioral: Social Media Intervention Not Applicable

Detailed Description:
This study is a randomized controlled trial of a social media intervention to support teens in their efforts to quit vaping.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Social Media Intervention to Stop Nicotine and Cannabis Vaping Among Adolescents
Estimated Study Start Date : July 1, 2021
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Experimental: Vaping Intervention
The vaping intervention will be implemented on Instagram. Participants in the treatment condition will be assigned to groups on Instagram, where they will receive up to 3 posts per day for 30 days. Groups are facilitated by a trained Guide, working with the Principal Investigator, Co-Investigators and a Pediatrician on demand if additional expertise or clinical advice is needed. Participants will be educated about signs of nicotine dependence and if they express interest in pharmacotherapy will be encouraged to access this through their personal healthcare providers. The Instagram groups will provide educational and social support, troubleshooting and advice about nicotine replacement therapy (NRT) or other forms of treatment.
Behavioral: Social Media Intervention
Social media based intervention using Instagram with up to 3 posts per day for 30 days

No Intervention: Control Condition
Participants in the control condition will be directed to the Truth Initiative e-cigarette texting quit program. This innovative and free text message program was created with input from teens, college students and young adults who have attempted to, or successfully, quit e-cigarettes using text coaching methods



Primary Outcome Measures :
  1. Point Prevalent Abstinence (PPA) from vaping [ Time Frame: 1 month ]
    7-day point prevalence abstinence (PPA) from all tobacco products will be assessed over the course of the study. Participants reporting no vaping in the past 7 days will be coded as abstinent. Those reporting 7-day abstinence and not using nicotine replacement therapy will be mailed saliva cotinine test kit and saliva tetrahydrocannabinol (THC) test kit for biochemical verification of abstinence.

  2. Point Prevalent Abstinence (PPA) from vaping [ Time Frame: 3 months ]
    7-day point prevalence abstinence (PPA) from all tobacco products will be assessed over the course of the study. Participants reporting no vaping in the past 7 days will be coded as abstinent. Those reporting 7-day abstinence and not using nicotine replacement therapy will be mailed saliva cotinine test kit and saliva tetrahydrocannabinol (THC) test kit for biochemical verification of abstinence.

  3. Point Prevalent Abstinence (PPA) from vaping [ Time Frame: 6 months ]
    7-day point prevalence abstinence (PPA) from all tobacco products will be assessed over the course of the study. Participants reporting no vaping in the past 7 days will be coded as abstinent. Those reporting 7-day abstinence and not using nicotine replacement therapy will be mailed saliva cotinine test kit and saliva tetrahydrocannabinol (THC) test kit for biochemical verification of abstinence.


Secondary Outcome Measures :
  1. Change in the number of participants with reduction in vaping [ Time Frame: Up to 6 months ]
    Reduction in vaping is defined as a decline in vaping frequency by 50 percent (%) or more.

  2. Change in the number of vape quit attempts [ Time Frame: Up to 6 months ]
    The number of quit attempts will be recorded at each assessment.

  3. Number of participants with at least 1 quit attempt [ Time Frame: Up to 6 months ]
    The number of participants whom achieved at least one quit attempt during the full assessment time period will be reported.

  4. Change in response on Stages of Change Questionnaire [ Time Frame: Up to 6 months ]
    The participants readiness to quit will be measured using the Stages of Change questionnaire - single item, which asks "Are you seriously thinking of quitting smoking?" Answers range from 'Yes, within the next 30 days', 'Yes, within the next 6 months', and 'No, not thinking of quitting'.

  5. Change in the score on the Thoughts About Abstinence (TAA) Questionnaire [ Time Frame: Up to 6 months ]
    The adapted Thoughts About Abstinence Questionnaire (Hall et al., 1991) is a 3 item self-report questionnaire that measures: 1) desire to quit smoking, 2) expected success at quitting, 3) expected difficulty of quitting on 10-point Likert scales (e.g., 1=no desire to quit/lowest expectation/lowest level of difficulty to 10 = extreme desire to quit/highest expectation of success/highest expected difficulty)

  6. Change in the scores on the Ways of Quitting questionnaire (WOQ) [ Time Frame: Up to 6 months ]
    The WOQ is a 28-item self-report instrument assessing adolescent smoking cessation strategies. For each WOQ item, respondents indicate whether they have used a given strategy (yes/no) and, if used, how helpful it was perceived to be on a five-point Likert-type scale (1= "Not helpful" to 5="Extremely helpful") with regard to several categories: Social support, Seeking assistance, Avoidance, Reduction, Substitution, Medication, Distraction, and Quit all at once (single item).



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. English literacy
  2. Age between 13-17 years
  3. Indicate they use social media "most" (>= 4) days per week
  4. Have vaped at least once per week in the past 30 days (90 percent of participants)
  5. Access to a computer or mobile phone with photo capability to verify abstinence from vaping
  6. Indicate they are considering quitting or are interested in quitting with the next 6 months or within the next 30 days
  7. Currently reside in California

Exclusion Criteria:

  1. No English literacy
  2. Age under 13 or over 17
  3. Insufficient social media use (3 or fewer days per week)
  4. Have not vaped at least once per week in past 30 days
  5. No access to computer or mobile phone with photo capability to verify abstinence from vaping
  6. Not considering or interested in quitting vaping in the next 30 days or 6 months;
  7. Not a California resident

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): NCT04707911


Contacts
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Contact: Sarah Olson, BA 415-502-0758 quitthehit@ucsf.edu

Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Contact: Sarah Olson    415-502-0758    quitthehit@ucsf.edu   
Principal Investigator: Pamela Ling, MD         
Sponsors and Collaborators
University of California, San Francisco
Tobacco Related Disease Research Program
HopeLab Foundation
Investigators
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Principal Investigator: Pamela Ling, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04707911    
Other Study ID Numbers: T31IR1910
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Nicotine Dependence
Social Media
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders