New Strategies to Enhance Smoking Cessation

Not Applicable

Not yet recruiting

• Conditions: Smoking Cessation

• Registration Number: NCT06751927
• Lead Sponsor: University of Chicago

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Study First Posted: 2024-12-30
• Last Update Posted: 2024-12-30
• Study Start: 2025-03
• Primary Completion: 2028-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acceptability of the experimental video intervention	24 weeks	This will be assessed using a modified version of the Client Satisfaction Questionnaire which assesses items such as quality, effectiveness, and intrusiveness on the 10-point Likert scale (0=not at all, 10=very much).
Determine whether provision of technology access and support will improve program attendance and smoking outcomes	24 weeks	This will be assessed using a modified version of the Client Satisfaction Questionnaire specific to technology component which assesses items such as quality, effectiveness, and intrusiveness on the 10-point Likert scale (0=not at all, 10=very much).
Trial feasibility	End of study recruitment (6 months)	ability to enroll and follow-up with the planned number of participants within the specified time frame.