Smoking Cessation Clinical Trial
— Tweet2QuitOfficial title:
Social Media Technology for Treating Tobacco Addiction
Verified date | May 2023 |
Source | University of California, Irvine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Tweet2Quit is an innovative smoking cessation intervention that combines real-time online peer-to-peer support with auto messaging. In a three-group randomized controlled trial, the investigators will compare: 1) usual care, 2) Tweet2Quit-coed, and 3) Tweet2Quit-Women only.
Status | Completed |
Enrollment | 960 |
Est. completion date | September 2022 |
Est. primary completion date | September 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 59 Years |
Eligibility | Inclusion Criteria: - Are 21-59 years of age - Are smoking 5+ cigarettes/day and 100+ cigarettes in one's lifetime - In the preparation stage of quitting smoking - Are English speaking - Have a mobile phone with an unlimited texting plan and internet access (via mobile phone) - Text at least once a week - Are a social media user - Have an active email account - Lives in the continental USA Exclusion Criteria: - Have certain medical conditions that are contraindicated for nicotine replacement therapy: pregnant, breast feeding, a recent heart attack, an irregular heartbeat, high blood pressure not controlled with medication, skin allergies to adhesive tape or serious skin problems, taking a prescription medicine for depression, and/or any other medical conditions that would prevent you from completing this study. - Are an illicit hard drug user or regular marijuana user - Share a household with someone else or has an immediate family member who has already enrolled in the study currently or in the past or if the participant has already been enrolled or failed to pass the screening once already since October 2016 - Participated in Tweet2Quit between 2012-2013 in a Twitter group and was not an active tweeter (<1 week) - Fails to provide valid forms of all the required personal contact information |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Irvine - Paul Merage School of Business | Irvine | California |
United States | Stanford University School of Medicine | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Irvine | National Cancer Institute (NCI), Stanford University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Percentage of participants with a 7-Day point prevalence abstinence | Percentage of participants who reported no use of tobacco products by answering the questions: 'How many cigarettes have you smoked', 'How many other tobacco products have you used', and 'How many times have you used an e-cig' over the past 7 days (assessed at 1 month post quit date). | 1 Month | |
Other | Percentage of participants with a 7-Day point prevalence abstinence | Percentage of participants who reported no use of tobacco products by answering the questions: 'How many cigarettes have you smoked', 'How many other tobacco products have you used', and 'How many times did you use an e-cig' over the past 7 days (assessed at 3 months post quit date) confirmed by salivary cotinine measurement (assessed at 3 months post quit date). A result level of 0 (0-10ng/ml) will be considered abstinent. Additionally if the participant reports living with a heavy smoker, then a result of 1 (10-30ng/ml) or lower will be considered abstinent. | 3 Month | |
Other | Percentage of participants with a 7-Day point prevalence abstinence | Percentage of participants who reported no use of tobacco products by answering the questions: 'How many cigarettes have you smoked', 'How many other tobacco products have you used', and 'How many times did you use an e-cig' over the past 7 days (assessed at 6 months post quit date) confirmed by salivary cotinine measurement (assessed at 6 months post quit date). If participants report abstinence on the 6-month survey they will be given a saliva test to bioconfirm their abstinence. A result level of 0 (0-10ng/ml) will be considered abstinent. Additionally if the participant reports living with a heavy smoker, then a result of 1 (10-30ng/ml) or lower will be considered abstinent. | 6 Month | |
Primary | Percentage of participants with a 6-month sustained abstinence | Percentage of participants who reported no use of tobacco products by answering the questions: 'How many cigarettes have you smoked', 'How many other tobacco products have you used', and 'How many times have you used e-cigs' since the quit date (assessed at 1, 3 and 6 months post quit date) confirmed by salivary cotinine measurement (assessed at 3 and 6 months post quit date). Note: We will apply the Russell Standard for abstinence, allowing 5 or fewer instances of tobacco use over 6 months.
In our primary (most rigorous) analysis, we will consider a cotinine-positive test, regardless of source, to be non-abstinent. In additional analyses, we will code as abstinent those who assert tobacco abstinence but continue use of FDA-approved nicotine replacement therapy. In other analyses we will report results with ENDS-only users coded first as non-abstinent and then for comparison as abstinent. |
6 Month | |
Secondary | Percentage of participants with a 3-month sustained abstinence | Percentage of participants who reported no use of tobacco products by answering the questions: 'How many cigarettes have you smoked', 'How many other tobacco products have you used' and 'How many times have you used an e-cig' since the quit date (assessed at 1 and 3 months post quit date) confirmed by salivary cotinine measurement (assessed at 3 months post quit date). Note: We will apply the Russell Standard for abstinence, allowing 5 or fewer instances of tobacco use over 3 months. | 3 Month |
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