New Strategies to Enhance Smoking Cessation

The University of Chicago

Status: Enrolling

Conditions: Smoking Cessation

Treatments: Behavioral: Educational Video

Study type: Interventional

Funder types: Other

Identifiers

NCT06751927

IRB24-1204

Details and patient eligibility

About

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.

Enrollment: 94 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients must smoke at least 10 cigarettes/day and do not currently use a smoking cessation medication.
• 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 receiving any other smoking cessation medications.
• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

94 participants in 3 patient groups

Educational Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Educational Video

Treatment-as-usual (TAU)

No Intervention group

Description:

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.

Focus Group

No Intervention group

Description:

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