Social Media Intervention to Stop Nicotine and Cannabis Vaping Among Adolescents

• ClinicalTrials.gov Identifier: NCT04707911
• Recruitment Status: Recruiting
• First Posted: January 13, 2021
• Last Update Posted: November 22, 2021
• Sponsor: University of California, San Francisco
• Collaborators: Tobacco Related Disease Research Program; HopeLab Foundation; Rescue Agency
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

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.

Study Design

• 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
• Actual Study Start Date: November 18, 2021
• Estimated Primary Completion Date: July 31, 2024
• Estimated Study Completion Date: July 31, 2024

Arms and Interventions

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

Outcome Measures

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).

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Sarah Rosen, BA; 415-502-0758; quitthehit@ucsf.edu

Locations

United States, California

University of California, San Francisco; Recruiting

San Francisco, California, United States, 94143

Contact: Sarah Rosen, BA 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

Rescue Agency

Investigators

• Principal Investigator: Pamela Ling, MD; University of California, San Francisco

More Information

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT04707911
• Other Study ID Numbers: T31IR1910; 21633 ( Other Identifier: University of California, San Francisco )
• First Posted: January 13, 2021
• Last Update Posted: November 22, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Marijuana Abuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders