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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03069924
Other study ID # Pro00055397
Secondary ID 5R01CA207229-06
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date July 1, 2017
Est. completion date November 10, 2024

Study information

Verified date January 2024
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research is a randomized smoking cessation trial conducted within and specifically personalized for lung cancer screening patients presenting to a lung screening clinic. Novel tobacco treatments for this population are critically needed, given the growing population of lung screening patients, which will grow dramatically now that lung screening is an approved CMS benefit. In the proposed study, we will test a gain-framed messaging intervention specifically designed for lung screening patients (vs. unframed messaging), as well as evaluating NRT sampling (vs. no medication) at 2 study sites. Our project is designed to be translational (in that it can be transferable from our controlled efficacy study to other lung screening programs).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 367
Est. completion date November 10, 2024
Est. primary completion date November 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: 1. 50 years or older 2. at least a 20-pack year history of smoking 3. current smoker (defined as any smoking in the past 30 days) 4. willing to be randomized 5. English speaking Exclusion Criteria: 1. unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia, 2. known allergy to adhesives 3. being in the immediate (within 2 weeks) post myocardial infarction period 4. serious arrhythmias 5. unstable angina pectoris 6. hemodynamically or electrically unstable. 7. current participation in another tobacco treatment program (e.g., using medication from a primary care doctor, Quitline, etc.)

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
Gain-framed messaging plus NRT
Gain-framed messaging materials and NRT
Behavioral:
Unframed messaging materials
Unframed smoking cessation materials

Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina
United States Yale Cancer Center New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Medical University of South Carolina National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Smoking cessation rates NRT+Gain-framed messaging vs. No NRT+Unframed messaging 6 month follow-up
Secondary Smoking cessation rates Gain-framed messaging + NRT & Unframed messaging + NRT vs. Gain-framed messaging + No NRT & Unframed messaging + No NRT 6 month follow-up
Secondary Smoking cessation rates Gain-framed messaging + NRT & Gain-framed messaging + No NRT vs. Unframed messaging + NRT & Unframed messaging + No NRT 6 month follow-up
Secondary Smoking cessation rates Gain-framed messaging + NRT & Gain-framed messaging + No NRT & Unframed messaging + NRT vs. Unframed messaging + No NRT 6 month follow-up
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