Smoking Tobacco and Drinking Study

NCT03163303 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: P0509092R34DA041637
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will test the efficacy of a 3-month intervention on Facebook targeting tobacco use and heavy episodic drinking against a 3-month Facebook intervention targeting tobacco use. Both groups will be offered a nicotine patch starter kit. The primary outcome is verified 7-day point prevalence abstinence from smoking at 3, 6, and 12 months.

Conditions

Smoking; Heavy Episodic Drinking

Keywords

Tobacco; Cigarettes; Alcohol; Cessation; Intervention; Young adults; Internet; Social media

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Reported 7-day Point Prevalence Abstinence at 3 Months

  Point prevalent abstinence was defined as biochemically-verified reports of no smoking in the 7 days prior to the 3 month assessment. Participants reporting no smoking in the past 7 days will be coded as abstinent from cigarettes. Participants with a salivary cotinine level \<11 ng/ml, indicating nonsmoking were considered confirmed nonsmokers

  3 months post baseline

• Number of Participants With Reported 7-day Point Prevalence Abstinence at 6 Months

  Point prevalent abstinence was defined as biochemically-verified reports of no smoking in the 7 days prior to the 6 month assessment. Participants reporting no smoking in the past 7 days will be coded as abstinent from cigarettes. Participants with a salivary cotinine level \<11 ng/ml, indicating nonsmoking were considered confirmed nonsmokers

  6 months post baseline

• Number of Participants With Reported 7-day Point Prevalence Abstinence at 12 Months

  Point prevalent abstinence was defined as biochemically-verified reports of no smoking in the 7 days prior to the 12 month assessment. Participants reporting no smoking in the past 7 days will be coded as abstinent from cigarettes. Participants with a salivary cotinine level \<11 ng/ml, indicating nonsmoking were considered confirmed nonsmokers

  12 months post baseline

Secondary Outcomes (11)

• Number of Participants With a Reduction in Cigarettes Smoked Over Time

  3, 6, and 12 months post baseline

• Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment

  3, 6, and 12 month post-baseline

• Number of Participant Reporting a Readiness to Quit Tobacco Use Over Time

  3, 6, and 12 months post-baseline

• Average Score on the Thoughts About Abstinence Questionnaire (Smoking)

  At Baseline

• Average Number of Days of Heavy Episodic Drinking (HED) Over Time

  3, 6, and 12 months post-baseline

Study Arms (2)

Tobacco Status Project (TSP) + Alcohol Intervention

EXPERIMENTAL

Tobacco and alcohol intervention on Facebook and 14-day nicotine patch

Behavioral: Tobacco Status Project + Alcohol Intervention; Drug: nicotine patch

Tobacco Status Project Intervention

EXPERIMENTAL

Tobacco intervention on Facebook and 14-day nicotine patch

Behavioral: Tobacco Status Project Intervention; Drug: nicotine patch

Interventions

Tobacco Status Project Intervention BEHAVIORAL

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

Tobacco Status Project Intervention

Tobacco Status Project + Alcohol Intervention BEHAVIORAL

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

Tobacco Status Project (TSP) + Alcohol Intervention

nicotine patch DRUG

14-day supply of nicotine patch

Tobacco Status Project (TSP) + Alcohol Intervention; Tobacco Status Project Intervention

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• have had at least one heavy drinking episode (5+ for men, 4+ for women) in the past month.

You may not qualify if:

• 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
• have not had at least one heavy drinking episode (5+ for men, 4+ for women) in the past month.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of California San Francisco Department of Psychiatry

San Francisco, California, 94143, United States

Location

Related Publications (2)

• Meacham MC, Ramo DE, Prochaska JJ, Maier LJ, Delucchi KL, Kaur M, Satre DD. A Facebook intervention to address cigarette smoking and heavy episodic drinking: A pilot randomized controlled trial. J Subst Abuse Treat. 2021 Mar;122:108211. doi: 10.1016/j.jsat.2020.108211. Epub 2020 Nov 23.

  PMID: 33509414 DERIVED

• Ramo DE, Meacham MC, Kaur M, Corpuz ES, Prochaska JJ, Satre DD. Development of a social media-based intervention targeting tobacco use and heavy episodic drinking in young adults. Addict Sci Clin Pract. 2019 Apr 1;14(1):14. doi: 10.1186/s13722-019-0141-9.

  PMID: 30940206 DERIVED

MeSH Terms

Conditions

Smoking

Interventions

Ethanol; Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Therapeutics

Limitations and Caveats

Self-reported vaping frequency may have impacted biochemically verified nicotine abstinence validity

Results Point of Contact

• Title: Dr. Derek Satre
• Organization: University of California, San Francisco

derek.satre@ucsf.edu

(415) 476-7382

Study Officials

• Derek Satre, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: May 23, 2017
• Study Start: December 18, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: August 12, 2020
• Results First Posted: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)