CClinicalTrials.gg
RecruitingNCT06751927Updated Jun 11, 2025

New Strategies to Enhance Smoking Cessation

An interventional study of Educational Video in Smoking Cessation, sponsored by University of Chicago. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-11.

Sponsored by University of Chicago · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
94
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Smoking Cessation
03

In context

Lead sponsor

University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
94 participants (estimated)

Study 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.

    Behavioral: Educational Video

  • 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

  • BehavioralEducational Video

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

06

What researchers measure

Primary outcomes

  1. Acceptability of the experimental video intervention

    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).

    Time frame: 24 weeks

  2. Determine whether provision of technology access and support will improve program attendance and smoking outcomes

    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).

    Time frame: 24 weeks

  3. Trial feasibility

    ability to enroll and follow-up with the planned number of participants within the specified time frame.

    Time frame: End of study recruitment (6 months)

07

Study locations

1 of 1 sites recruiting
  • University of Chicago
    Chicago, Illinois 60637, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Are the UChicago researchers conducting this study or any portion of the study at a non-UChicago site ? NO

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06751927
Lead sponsor
University of Chicago
Responsible party
Sponsor
First posted
Dec 30, 2024
Start date
Apr 24, 2025
Primary completion
Dec 2028 (estimated)
Completion
Dec 2030 (estimated)
Last update
Jun 11, 2025

Study contacts

Clinical Trials Intake
Contact
cancerclinicaltrials@bsd.uchicago.edu
1-855-702-8222
Andrea C. King
principal investigator · University of Chicago

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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