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NCT Number: NCT06751927

New Strategies to Enhance Smoking Cessation

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.

Recruiting

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

Location status: Recruiting

Location contact

Andrea King

PRINCIPAL_INVESTIGATOR

Clinical Trials Intake

CONTACT

[email protected]

855-702-8222

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Educational Video

Behavioral

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

Primary outcomes

  1. Acceptability of the experimental video intervention

    Time frame: 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).

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

    Time frame: 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).

  3. Trial feasibility

    Time frame: End of study recruitment (6 months)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Intake

CONTACT

[email protected]

1-855-702-8222

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Dec 30, 2024
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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