Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
94 participants
INTERVENTIONAL
2025-04-24
2030-12-31
Brief Summary
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There are 2 parts to this study:
* Part 1: Focus Group to help develop the educational tool intervention
* Part 2: Randomized portion of study. In this part of the study, participants will be randomized (like flip of coin) to take part in receive the experimental educational intervention or usual methods to help stop smoking. Participants in either arm can choose to receive varenicline and it will be provided as part of study.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Educational Intervention
Study participants will watch a video containing research findings related to smoking cessation and information on varenicline, a medication to help patients quit smoking.
For participants who select varenicline and/or nicotine replacement, medications will be mailed to their residence and standard follow-up and medication support practices will be adhered to check on progress.
Participants will be randomized to between educational intervention and usual care arm.
Some participants who have no access to a video-enabled device or reliable internet and will provide them a tablet with broadband internet for a period of 3 months.
Educational Video
Education video on smoking, nicotine receptor involvement in addiction, craving, withdrawal and mechanisms of action for nicotine replacement and varenicline.
Treatment-as-usual (TAU)
Treatment-as-usual (TAU) session with discussion of FDA-approved smoking medication. Treatment as usual includes discussion and facts about cessation medication options as a standard of care with a standard video on smoking cessation treatment.
For participants who select varenicline and/or nicotine replacement, medications will be mailed to their residence and standard follow-up and medication support practices will be adhered to check on progress.
Some participants who have no access to a video-enabled device or reliable internet and will provide them a tablet with broadband internet for a period of 3 months.
No interventions assigned to this group
Focus Group
3 focus groups with 6-8 patients each to provide feedback on video production format and salience of relevant content
No interventions assigned to this group
Interventions
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Educational Video
Education video on smoking, nicotine receptor involvement in addiction, craving, withdrawal and mechanisms of action for nicotine replacement and varenicline.
Eligibility Criteria
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Inclusion Criteria
* Ages 18-75.
* Agree to complete surveys and measures within study.
* Ability to understand English and the willingness to sign a written informed consent document.
Exclusion Criteria
* Patients who are pregnant and/or lactating.
* Patients with psychiatric contraindications that can prevent adherence to protocol or use of intervention tools in study. For inclusivity on trial, psychiatric contraindications and ability for patient to participate in trial will be assessed on an individual basis by study investigator.
* Patients who have a contraindication with varenicline.
18 Years
75 Years
ALL
Yes
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Andrea C. King
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB24-1204
Identifier Type: -
Identifier Source: org_study_id
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