SmokingPhase 4STANDNCT03163303
Smoking Tobacco and Drinking Study
A Phase 4 study testing Tobacco Status Project Intervention, Tobacco Status Project + Alcohol Intervention and nicotine patch in people with Smoking and Heavy Episodic Drinking, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Heavy Episodic Drinking
- What is being tested?
- Tobacco Status Project Intervention, Tobacco Status Project + Alcohol Intervention and nicotine patch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2017to 30 Jun 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco Department of Psychiatry
San Francisco, California, 94143
About this study
Official title: Using Facebook to Address Smoking and Heavy Drinking in Young Adults
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.
Read the detailed description
Participants will be randomized to one of two conditions: (1) a Facebook-delivered intervention addressing tobacco use and heavy episodic drinking, tailored to readiness to quit smoking; or (2) a 3-month Facebook intervention targeting tobacco use. Both interventions will include 12 weeks of Facebook-based messages and activities tailored to participants' readiness to quit smoking.
Assessments will occur at baseline, 3, 6, and 12 months follow-up. Assessments will include measures on smoking and drinking patterns and thoughts about abstinence. All participants who report no past 7-day smoking will be asked to give biochemical verification of smoking status with saliva cotinine test kits that will be mailed to participants.
- Conditions
- Smoking, Heavy Episodic Drinking
- Being tested
- Tobacco Status Project Intervention, Tobacco Status Project + Alcohol Intervention, nicotine patch
- Keywords
- Tobacco, Cigarettes, Alcohol, Cessation, Intervention, Young adults, Internet, Social media
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco Status Project InterventionBehavioural
90 days of Facebook messaging, weekly live sessions targeting tobacco use
Tobacco Status Project + Alcohol InterventionBehavioural
90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use
nicotine patchDrug
14-day supply of nicotine patch
| Study group | Role | What they receive |
|---|---|---|
| Tobacco Status Project (TSP) + Alcohol Intervention | Experimental | Tobacco and alcohol intervention on Facebook and 14-day nicotine patch Receives: Behavioral: Tobacco Status Project + Alcohol Intervention; Drug: nicotine patch |
| Tobacco Status Project Intervention | Experimental | Tobacco intervention on Facebook and 14-day nicotine patch Receives: Behavioral: Tobacco Status Project Intervention; Drug: nicotine patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 12 months post baseline
Secondary outcomes (11)
Number of Participants With a Reduction in Cigarettes Smoked Over Time
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
Measured: 3, 6, and 12 months post baseline
Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment
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.
Measured: 3, 6, and 12 month post-baseline
Number of Participant Reporting a Readiness to Quit Tobacco Use Over Time
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
Measured: 3, 6, and 12 months post-baseline
Average Score on the Thoughts About Abstinence Questionnaire (Smoking)
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.
Measured: At Baseline
Average Number of Days of Heavy Episodic Drinking (HED) Over Time
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.
Measured: 3, 6, and 12 months post-baseline
Median Number of Drinks Per Week Over Time
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.
Measured: 3, 6, and 12 months post-baseline
Average Score on the Alcohol Use Disorder Identification Test - Concise (AUDIT-C) Over Time
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 drinking or active alcohol use disorders. In women, a score of 3 or more is considered positive. Participants were given this assessment at months 3, 6, and 12.
Measured: 3, 6, and 12 months post-baseline
Alcohol Quit Attempt
Follow-up Drinking Questionnaire will assess the presence and number of 24 hr quit attempts since the last assessment. This assessment will be used to calculate presence of at least one quit attempt in the assessment time period and scored as a yes or no.
Measured: 3, 6, and 12 months post-baseline
Readiness to Change Alcohol Use Over Time
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
Measured: 3, 6, and 12 months post-baseline
Average Score on the Thoughts About Abstinence Questionnaire (Heavy Episodic Drinking) Over Time
The Thoughts About Abstinence Questionnaire (TAAS, (Hall et al., 1991) is a 4 item self-report questionnaire that measures: 1) desire to quit heavy episodic drinking, 2) expected success at quitting, 3) expected difficulty of quitting, and 4) confidence in ability to quit on 10-point Likert scales (e.g., 1=no desire to quit; 10 = extremely ...adapted for heavy episodic alcohol use
Measured: 3, 6, and 12 months post-baseline
Number of Participants With Reported Combined Use Using Tobacco or Alcohol Over Time
Timeline Follow-back data will be used to calculate the sum of days using any tobacco or binge drinking in the past month.
Measured: 3, 6, and 12 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start18 Dec 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Derek Satre, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163303
- Sponsor's protocol ID
- P0509092
- Other IDs
- R34DA041637
- Acronym
- STAND
- Status last verified
- Aug 2020
- First submitted
- 19 May 2017
- Last updated
- 12 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be de-identified and transferred to Dr. Chris Yang, expert on social media analytics at Drexel University, for analysis
Publications
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.
PubMed 33509414Ramo 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.
PubMed 30940206
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Facebook to Address Smoking and Heavy Drinking in Young Adults
- ClinicalTrials.gov ID
- NCT03163303
- Acronym / sponsor ID
- STAND / P0509092
- Conditions
- Smoking, Heavy Episodic Drinking
- Keywords
- Tobacco, Cigarettes, Alcohol, Cessation, Intervention, Young adults, Internet, Social media
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 23 May 2017 (actual)
- Results
- Posted 12 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will be randomized to one of two conditions: (1) a Facebook-delivered intervention addressing tobacco use and heavy episodic drinking, tailored to readiness to quit smoking; or (2) a 3-month Facebook intervention targeting tobacco use. Both interventions will include 12 weeks of Facebook-based messages and activities tailored to participants' readiness to quit smoking.
Assessments will occur at baseline, 3, 6, and 12 months follow-up. Assessments will include measures on smoking and drinking patterns and thoughts about abstinence. All participants who report no past 7-day smoking will be asked to give biochemical verification of smoking status with saliva cotinine test kits that will be mailed to participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tobacco Status Project (TSP) + Alcohol Intervention | Experimental | Behavioral: Tobacco Status Project + Alcohol Intervention, Drug: nicotine patchTobacco and alcohol intervention on Facebook and 14-day nicotine patch |
| Tobacco Status Project Intervention | Experimental | Behavioral: Tobacco Status Project Intervention, Drug: nicotine patchTobacco intervention on Facebook and 14-day nicotine patch |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tobacco Status Project Intervention90 days of Facebook messaging, weekly live sessions targeting tobacco use | Behavioural | Tobacco Status Project Intervention |
| Tobacco Status Project + Alcohol Intervention90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use | Behavioural | Tobacco Status Project (TSP) + Alcohol Intervention |
| nicotine patch14-day supply of nicotine patch | Drug | Tobacco Status Project (TSP) + Alcohol Intervention, Tobacco Status Project Intervention |
Primary outcome
Number of Participants With Reported 7-day Point Prevalence Abstinence at 3 Months
Time frame: 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
Number of Participants With Reported 7-day Point Prevalence Abstinence at 6 Months
Time frame: 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
Number of Participants With Reported 7-day Point Prevalence Abstinence at 12 Months
Time frame: 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
11 secondary outcomes
Number of Participants With a Reduction in Cigarettes Smoked Over Time
Time frame: 3, 6, and 12 months post baseline
Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment
Time frame: 3, 6, and 12 month post-baseline
Number of Participant Reporting a Readiness to Quit Tobacco Use Over Time
Time frame: 3, 6, and 12 months post-baseline
Average Score on the Thoughts About Abstinence Questionnaire (Smoking)
Time frame: At Baseline
Average Number of Days of Heavy Episodic Drinking (HED) Over Time
Time frame: 3, 6, and 12 months post-baseline
Median Number of Drinks Per Week Over Time
Time frame: 3, 6, and 12 months post-baseline
Average Score on the Alcohol Use Disorder Identification Test - Concise (AUDIT-C) Over Time
Time frame: 3, 6, and 12 months post-baseline
Alcohol Quit Attempt
Time frame: 3, 6, and 12 months post-baseline
Readiness to Change Alcohol Use Over Time
Time frame: 3, 6, and 12 months post-baseline
Average Score on the Thoughts About Abstinence Questionnaire (Heavy Episodic Drinking) Over Time
Time frame: 3, 6, and 12 months post-baseline
Number of Participants With Reported Combined Use Using Tobacco or Alcohol Over Time
Time frame: 3, 6, and 12 months post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33509414Meacham 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.
- Derived from this study: PubMed 30940206Ramo 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.
- Individual participant dataSharing planned: Yes. All data will be de-identified and transferred to Dr. Chris Yang, expert on social media analytics at Drexel University, for analysis
Related trials for Smoking
Not yet recruiting
The Effects of Manual Acupuncture on Superoxide Dismutase Enzyme Activity and Questionnaire of Smoking Urges-Brief Scores in Active Smokers: A Randomized Controlled Trial
Superoxide Dismutase, Acupuncture
Recruiting
Smoking Cessation in Patients With Cancer
Cancer, Tobacco Use
RecruitingPhase 1
Nicotinic Receptor Genetic Variation and Alcohol Reward
Alcohol Drinking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
Effectiveness Of Project EX: A Classroom-Based Smoking Prevention And Cessation Intervention Program
Focus of the Study is Smoking Cessation and Prevention, Smoking Prevention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek Satre, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tobacco Status Project Intervention, Tobacco Status Project + Alcohol Intervention and nicotine patch in people with Smoking and Heavy Episodic Drinking, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Reported 7-day Point Prevalence Abstinence at 3 Months (time frame: 3 months post baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03163303, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.