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Smoking Tobacco and Drinking Study (STAND)

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ClinicalTrials.gov Identifier: NCT03163303
Recruitment Status : Active, not recruiting
First Posted : May 23, 2017
Last Update Posted : June 8, 2018
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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: Tobacco Status Project + 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. 7-day point prevalence abstinence at 3 months [ Time Frame: 3 months post baseline ]
    Reports of no smoking in the 7 days prior to the 3 month assessment. Biochemical verification of abstinence will also be recorded.Biochemical verification of abstinence will also be recorded.

  2. 7-day point prevalence abstinence at 6 months [ Time Frame: 6 months post baseline ]
    Reports of no smoking in the 7 days prior to the 6 month assessment. Biochemical verification of abstinence will also be recorded.Biochemical verification of abstinence will also be recorded.

  3. 7-day point prevalence abstinence at 12 months [ Time Frame: 12 months post baseline ]
    Reports of no smoking in the 7 days prior to the 12 month assessment. Biochemical verification of abstinence will also be recorded.Biochemical verification of abstinence will also be recorded.


Secondary Outcome Measures :
  1. Reduction in cigarettes smoked by at least 50% between Baseline and each follow-up timepoint [ Time Frame: 3, 6, and 12 months post baseline ]
    Reduction will be assessed at 3, 6, and 12 month follow-ups.

  2. Tobacco use quit attempts [ Time Frame: 3, 6, and 12 month post-baseline ]
    Whether a quit attempt was made during the follow-up period at 3, 6, and 12 months post-baseline.

  3. Readiness to quit tobacco [ Time Frame: 3, 6, and 12 months post-baseline ]
    Proportion of participants ready to quit smoking in the next month assessed at 3, 6, and 12 months

  4. Days of heavy episodic drinking [ Time Frame: 3, 6, and 12 months post-baseline ]
    Number of days in the past 30 with 4+ drinks in an occasion for women and 5+ drinks for men

  5. Drinks per week [ Time Frame: 3, 6, and 12 months post-baseline ]
    Mean number of drinks per week in the past 30 days

  6. Misuse of alcohol in the past year [ Time Frame: 3, 6, and 12 months post-baseline ]
    Total score on the AUDIT-C

  7. Alcohol quit attempt [ Time Frame: 3, 6, and 12 months post-baseline ]
    Whether an attempt to quit alcohol was made during the follow-up period

  8. Readiness to change alcohol use [ Time Frame: 3, 6, and 12 months post-baseline ]
    Proportion of participants ready to change drinking in the next month assessed at 3, 6, and 12 months

  9. Thoughts About Alcohol Abstinence [ Time Frame: 3, 6, and 12 months post-baseline ]
    Desire to quit, abstinence self-efficacy, perceived difficulty of quitting and abstinence goal

  10. Thoughts About Tobacco Abstinence [ Time Frame: 3, 6, and 12 months post-baseline ]
    Desire to quit, abstinence self-efficacy, perceived difficulty of quitting and abstinence goal



Information from the National Library of Medicine

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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
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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
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Principal Investigator: Danielle E Ramo, PhD University of California, San Francisco

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03163303     History of Changes
Other Study ID Numbers: P0509092
R34DA041637 ( U.S. NIH Grant/Contract )
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Ethanol
Nicotine
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action