Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Smoking Tobacco and Drinking Study (STAND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03163303
Recruitment Status : Completed
First Posted : May 23, 2017
Results First Posted : August 12, 2020
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Smoking Heavy Episodic Drinking Behavioral: Tobacco Status Project Intervention Behavioral: Tobacco Status Project + Alcohol Intervention Drug: nicotine patch Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Using Facebook to Address Smoking and Heavy Drinking in Young Adults
Actual Study Start Date : December 18, 2017
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: Tobacco Status Project (TSP) + Alcohol Intervention
Tobacco and alcohol intervention on Facebook and 14-day nicotine patch
Behavioral: Tobacco Status Project + Alcohol Intervention
90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use

Drug: nicotine patch
14-day supply of nicotine patch

Experimental: Tobacco Status Project Intervention
Tobacco intervention on Facebook and 14-day nicotine patch
Behavioral: Tobacco Status Project Intervention
90 days of Facebook messaging, weekly live sessions targeting tobacco use

Drug: nicotine patch
14-day supply of nicotine patch




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. Number of Participants With a Reduction in Cigarettes Smoked Over Time [ Time Frame: 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

  2. Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment [ Time Frame: 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.

  3. Number of Participant Reporting a Readiness to Quit Tobacco Use Over Time [ Time Frame: 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

  4. Average Score on the Thoughts About Abstinence Questionnaire (Smoking) [ Time Frame: 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.

  5. Average Number of Days of Heavy Episodic Drinking (HED) Over Time [ Time Frame: 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.

  6. Median Number of Drinks Per Week Over Time [ Time Frame: 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.

  7. Average Score on the Alcohol Use Disorder Identification Test - Concise (AUDIT-C) Over Time [ Time Frame: 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 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.

  8. Alcohol Quit Attempt [ Time Frame: 3, 6, and 12 months post-baseline ]
    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.

  9. Readiness to Change Alcohol Use Over Time [ Time Frame: 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

  10. Average Score on the Thoughts About Abstinence Questionnaire (Heavy Episodic Drinking) Over Time [ Time Frame: 3, 6, and 12 months post-baseline ]
    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

  11. Number of Participants With Reported Combined Use Using Tobacco or Alcohol Over Time [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03163303


Locations
Layout table for location information
United States, California
University of California San Francisco Department of Psychiatry
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
National Institute on Drug Abuse (NIDA)
Investigators
Layout table for investigator information
Principal Investigator: Derek Satre, PhD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Informed Consent Form  [PDF] February 8, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03163303    
Other Study ID Numbers: P0509092
R34DA041637 ( U.S. NIH Grant/Contract )
First Posted: May 23, 2017    Key Record Dates
Results First Posted: August 12, 2020
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data will be de-identified and transferred to Dr. Chris Yang, expert on social media analytics at Drexel University, for analysis

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Tobacco
Cigarettes
Alcohol
Cessation
Intervention
Young adults
Internet
Social media
Additional relevant MeSH terms:
Layout table for MeSH terms
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action