Recruiting

Varenicline

Sponsor:

University of Chicago

Code:

NCT06751927

Conditions

Smoking Cessation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Educational Video

Study Details

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.

Conditions

Smoking Cessation

Study ID

NCT06751927

Start date

Apr 24, 2025

Status verified date

Jun, 2025

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

94 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: 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 intervention: Focus Group

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

Interventions

Educational Video

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

Primary outcome measure

  • Acceptability of the experimental video intervention [ Time Frame: 24 weeks ]
  • Determine whether provision of technology access and support will improve program attendance and smoking outcomes [ Time Frame: 24 weeks ]
  • Trial feasibility [ Time Frame: End of study recruitment (6 months) ]

Central Contacts and Locations

Central contacts

Clinical Trials Intake

1-855-702-8222cancerclinicaltrials@bsd.uchicago.edu

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Clinical Trials Intake

855-702-8222cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator:

Andrea King

More Information

Sponsor

University of Chicago

Last update posted

Jun 11, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Chicago on 2025-06-11.