Educational Video for Smoking Cessation

Overseen By Clinical Trials Intake

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Must not be taking: Smoking cessation medications

Disqualifiers: Pregnancy, Lactation, Psychiatric issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

94 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The study goal is to get feedback on ways researchers can communicate complex research findings on smoking cessation to better inform patients' decisions to use medication and/or quit smoking. This will help researchers and clinicians to provide effective, easy-to-implement treatments designed to address tobacco-related health disparities in Black and other racial/ethnic subgroups. It will also help improve health literacy to change misperceptions and mistrust on uptake of varenicline and other medication for quitting smoking. A professionally made video will explain research findings relevant for varenicline's mechanisms and outcomes relative to other treatment options. 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.

Who Is on the Research Team?

Andrea C. King

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals aged 18-75 who currently smoke at least 10 cigarettes a day and are not using smoking cessation medication. Participants must be willing to complete surveys and sign consent forms.

Inclusion Criteria

I agree to fill out all required surveys and measures for the study.

I understand English and agree to sign a consent form.

I am between 18 and 75 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Focus Group

Participants provide feedback on video production format and content relevance

4 weeks

3 focus groups

Randomized Educational Intervention

Participants are randomized to receive either the experimental educational intervention or usual care to help stop smoking

24 weeks

Ongoing virtual support

Follow-up

Participants are monitored for progress and adherence to smoking cessation treatment

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Educational Video

Trial Overview The study tests an educational video designed to inform smokers about quitting strategies, specifically the use of varenicline compared to other methods. It includes focus groups for feedback on the tool, followed by random assignment to either receive this new intervention or usual quit-smoking aids.

How Is the Trial Designed?

Group I: Educational Intervention Experimental Treatment 1 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.

Group II: Focus Group Active Control 1 Intervention

3 focus groups with 6-8 patients each to provide feedback on video production format and salience of relevant content

Group III: Treatment-as-usual (TAU) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+