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New Strategies to Enhance Smoking Cessation

Uptake of Varenicline and Strategies for Enhanced Engagement in Treatment for Smoking Cessation

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06751927
Enrollment
94
Registered
2024-12-30
Start date
2025-04-24
Completion date
2030-12-31
Last updated
2025-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

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.

Interventions

BEHAVIORALEducational Video

Education video on smoking, nicotine receptor involvement in addiction, craving, withdrawal and mechanisms of action for nicotine replacement and varenicline.

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of the experimental video intervention24 weeksThis 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 outcomes24 weeksThis 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 feasibilityEnd of study recruitment (6 months)ability to enroll and follow-up with the planned number of participants within the specified time frame.

Countries

United States

Contacts

Primary ContactClinical Trials Intake
cancerclinicaltrials@bsd.uchicago.edu1-855-702-8222

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026