NCT03163303: STAND

Smoking Tobacco and Drinking Study

Completed Phase 4 Results posted Last updated 12 August 2020

What this trial tests

Phase 4 trial testing Tobacco Status Project Intervention in Smoking in 179 participants. Completed in 30 June 2019.

Timeline

18 December 2017

Primary endpoint
30 June 2019

30 June 2019

Quick facts

Lead sponsor	University of California, San Francisco
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	179
Start date	18 December 2017
Primary completion	30 June 2019
Estimated completion	30 June 2019
Sites	1 location across United States

Drugs / interventions tested

• Tobacco Status Project Intervention
• Tobacco Status Project + Alcohol Intervention
• nicotine patch (nicotine-patch) — full drug profile →

Conditions studied

• Smoking — all drugs for Smoking →
• Heavy Episodic Drinking — all drugs for Heavy Episodic Drinking →

Sponsor

University of California, San Francisco

Who can join

Adults 18 to 25, any sex, with Smoking or Heavy Episodic Drinking. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Reported 7-day Point Prevalence Abstinence at 3 Months Primary · 3 months post baseline

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

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	3
Tobacco Status Project Intervention	4

Number of Participants With Reported 7-day Point Prevalence Abstinence at 6 Months Primary · 6 months post baseline

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

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	0
Tobacco Status Project Intervention	1

Number of Participants With Reported 7-day Point Prevalence Abstinence at 12 Months Primary · 12 months post baseline

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

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	3
Tobacco Status Project Intervention	0

Number of Participants With a Reduction in Cigarettes Smoked Over Time Secondary · 3, 6, and 12 months post baseline

A reduction was defined as the number of cigarettes smoked in past 7 days prior to the assessment by 50% or more compared to baseline number of cigarettes at 3, 6, and 12 month

Month 3

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	32
Tobacco Status Project Intervention	35

Month 6

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	35
Tobacco Status Project Intervention	30

Month 12

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	46
Tobacco Status Project Intervention	46

Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment Secondary · 3, 6, and 12 month post-baseline

An attempt was defined by the participants response to the a question as to whether or not they had made an attempt to quit smoking during the course of treatment at the 3, 6, and 12 months post-baseline assessments. Participants who were determined to have made an attempt at least once during the entire course of treatment were scored as yes or no.

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	49
Tobacco Status Project Intervention	45

Number of Participant Reporting a Readiness to Quit Tobacco Use Over Time Secondary · 3, 6, and 12 months post-baseline

Readiness to change tobacco use will be assessed with a single-item Readiness Ruler, developed and validated for use with young adult heavy smokers participating in brief intervention and the tobacco item from the Staging Health Risk Assessment (S-HRA) to compare stage of change across tobacco and alcohol use. Plans to limit smoking in next 30 days (or is already). Number of participants ready to change smoking in the next month assessed at 3, 6, and 12 months

Month 3

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	37
Tobacco Status Project Intervention	27

Month 6

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	20
Tobacco Status Project Intervention	23

Month 12

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	34
Tobacco Status Project Intervention	41

Average Score on the Thoughts About Abstinence Questionnaire (Smoking) Secondary · At Baseline

The Thoughts About Abstinence Questionnaire (TAAS, (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) was assessed at baseline.

Desire to quit

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	6.1	± 2.6
Tobacco Status Project Intervention	5.9	± 2.5

Expected success

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	4.6	± 2.3
Tobacco Status Project Intervention	5.1	± 2.6

Expected difficulty

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	7.2	± 2.4
Tobacco Status Project Intervention	7.1	± 2.3

Average Number of Days of Heavy Episodic Drinking (HED) Over Time Secondary · 3, 6, and 12 months post-baseline

HED is defined as the number of days in the past month with 4+ drinks consumed in a a single occasion for women and 5+ drinks for men. HED was assessed at 3, 6 and 12 months.

Month 3

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	4.8	± 7
Tobacco Status Project Intervention	7.6	± 8.2

Month 6

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	3.8	± 5.5
Tobacco Status Project Intervention	6	± 7.8

Month 12

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	3.2	± 5.2
Tobacco Status Project Intervention	5.6	± 7.6

Median Number of Drinks Per Week Over Time Secondary · 3, 6, and 12 months post-baseline

The number of drinks per week was defined as drinks per week in the past 30 days and assessed at the 3,6,and 12 month assessments.

Month 3

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	4	0 – 12
Tobacco Status Project Intervention	6	0 – 17

Month 6

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	5	0 – 11
Tobacco Status Project Intervention	7	0 – 15

Month 12

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	1	0 – 7.8
Tobacco Status Project Intervention	4	0 – 16

Average Score on the Alcohol Use Disorder Identification Test - Concise (AUDIT-C) Over Time Secondary · 3, 6, and 12 months post-baseline

Misuse of alcohol in the past year was assessed by the AUDIT-C. The AUDIT-C is a brief alcohol screening instrument that reliably identifies persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence) and consists of 3 questions with a total score ranging from 0-12, and generally the higher the score, the more likely it is that a person's drinking is affecting his or her safety. Each AUDIT-C question has 5 answer choices valued from 0 points to 4 points. In men, a score of 4 or more is considered positive, optimal for identifying hazardous dr

Month 3

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	3.9	± 2.7
Tobacco Status Project Intervention	5	± 2.9

Month 6

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	3.7	± 2.7
Tobacco Status Project Intervention	4.8	± 3

Month 12

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	3.4	± 2.4
Tobacco Status Project Intervention	4.1	± 3.1

Readiness to Change Alcohol Use Over Time Secondary · 3, 6, and 12 months post-baseline

Readiness to change alcohol use will be assessed with a single-item Readiness Ruler, developed and validated for use with young adult heavy drinkers participating in brief intervention and the alcohol item from the Staging Health Risk Assessment (S-HRA) to compare stage of change across tobacco and alcohol use. Plans to limit drinking in next 30 days (or is already) Proportion of participants ready to change drinking in the next month assessed at 3, 6, and 12 months

Month 3

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	40
Tobacco Status Project Intervention	42

Month 6

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	28
Tobacco Status Project Intervention	38

Month 12

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	42
Tobacco Status Project Intervention	54

Number of Participants With Reported Combined Use Using Tobacco or Alcohol Over Time Secondary · 3, 6, and 12 months post-baseline

Timeline Follow-back data will be used to calculate the sum of days using any tobacco or binge drinking in the past month.

Month 3

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	48
Tobacco Status Project Intervention	63

Month 6

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	36
Tobacco Status Project Intervention	49

Month 12

Group	Value	95% CI
Tobacco Status Project + Alcohol Intervention	43
Tobacco Status Project Intervention	52

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Behavioural interventions delivered through interactive social media for health behaviour change, health outcomes, and health equity in the adult population.
   Petkovic J, Duench S, Trawin J, Dewidar O, et al · · 2021 · cited 78× · PMID 34057201 · DOI 10.1002/14651858.cd012932.pub2
2. A Facebook intervention to address cigarette smoking and heavy episodic drinking: A pilot randomized controlled trial.
   Meacham MC, Ramo DE, Prochaska JJ, Maier LJ, et al · · 2021 · cited 18× · PMID 33509414 · DOI 10.1016/j.jsat.2020.108211
3. Development of a social media-based intervention targeting tobacco use and heavy episodic drinking in young adults.
   Ramo DE, Meacham MC, Kaur M, Corpuz ES, et al · · 2019 · cited 14× · PMID 30940206 · DOI 10.1186/s13722-019-0141-9
4. Factors associated with readiness to quit smoking among young adults enrolled in a Facebook-based tobacco and alcohol intervention study.
   Maier LJ, Ramo DE, Kaur M, Meacham MC, et al · · 2020 · cited 4× · PMID 32791434 · DOI 10.1016/j.addbeh.2020.106524