New Strategies to Enhance Smoking Cessation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Educational Video.
- Who it may be relevant to
- Registry conditions: Smoking Cessation. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Uptake of Varenicline and Strategies for Enhanced Engagement in Treatment for Smoking Cessation
Overview
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
- Behavioral Educational Video
Education video on smoking, nicotine receptor involvement in addiction, craving, withdrawal and mechanisms of action for nicotine replacement and varenicline.
Primary outcome measures
- 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)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Chicago — Chicago
Identifiers
NCT: NCT06751927 · IRB24-1204