Phase 4
N=179
Smoking Tobacco and Drinking Study
Smoking · Heavy Episodic Drinking
Bottom Line
View on ClinicalTrials.gov: NCT03163303 ↗Enrolled (actual)
179
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Number of Participants With Reported 7-day Point Prevalence Abstinence at 3 Months — 3; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tobacco Status Project Intervention (Behavioral); Tobacco Status Project + Alcohol Intervention (Behavioral); nicotine patch (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Reported 7-day Point Prevalence Abstinence at 3 Months |
3; 4 | — |
| PRIMARY Number of Participants With Reported 7-day Point Prevalence Abstinence at 6 Months |
0; 1 | — |
| PRIMARY Number of Participants With Reported 7-day Point Prevalence Abstinence at 12 Months |
3; 0 | — |
| SECONDARY Number of Participants With a Reduction in Cigarettes Smoked Over Time |
32; 35; 35; 30; 46; 46 | — |
| SECONDARY Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment |
49; 45 | — |
| SECONDARY Number of Participant Reporting a Readiness to Quit Tobacco Use Over Time |
37; 27; 20; 23; 34; 41 | — |
| SECONDARY Average Score on the Thoughts About Abstinence Questionnaire (Smoking) |
6.1; 5.9; 4.6; 5.1; 7.2; 7.1 | — |
| SECONDARY Average Number of Days of Heavy Episodic Drinking (HED) Over Time |
4.8; 7.6; 3.8; 6; 3.2; 5.6 | — |
| SECONDARY Median Number of Drinks Per Week Over Time |
4; 6; 5; 7; 1; 4 | — |
| SECONDARY Average Score on the Alcohol Use Disorder Identification Test - Concise (AUDIT-C) Over Time |
3.9; 5; 3.7; 4.8; 3.4; 4.1 | — |
| SECONDARY Alcohol Quit Attempt |
— | — |
| SECONDARY Readiness to Change Alcohol Use Over Time |
40; 42; 28; 38; 42; 54 | — |
| SECONDARY Average Score on the Thoughts About Abstinence Questionnaire (Heavy Episodic Drinking) Over Time |
— | — |
| SECONDARY Number of Participants With Reported Combined Use Using Tobacco or Alcohol Over Time |
48; 63; 36; 49; 43; 52 | — |
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.
Eligibility 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
- have had at least one heavy drinking episode (5+ for men, 4+ for women) in the past month.
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
- have not had at least one heavy drinking episode (5+ for men, 4+ for women) in the past month.
Data sourced from ClinicalTrials.gov (NCT03163303). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.