Tobacco Use Cessation Clinical Trial
Official title:
Changing the Default for Tobacco Treatment
Verified date | November 2022 |
Source | University of Kansas Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the impact and efficacy of a new approach to smoking cessation treatment versus the traditional approach.
Status | Completed |
Enrollment | 1000 |
Est. completion date | December 9, 2020 |
Est. primary completion date | July 27, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Speak English or Spanish - Have access to a telephone or mobile phone - Not be currently pregnant or breast feeding - Have no significant co-morbidity that precludes participation - Current daily smoker - Not in treatment for tobacco dependence - Reside in Kansas or Missouri Exclusion Criteria: - Admission greater than 3 days |
Country | Name | City | State |
---|---|---|---|
United States | University of Kansas Medical Center | Kansas City | Kansas |
Lead Sponsor | Collaborator |
---|---|
University of Kansas Medical Center | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cost-effectiveness | Counselor time, wage estimates, pharmacotherapy costs, and abstinence rates will be combined to report the incremental cost-effective ratio (ICER). The ICER is the ratio of the difference in costs divided by the difference in effectiveness between the two study arms. ICER indicates the added cost per additional quitter, a metric that will allow comparisons to other smoking cessation economic studies. | Month 6 | |
Primary | 7-day Point-prevalence Abstinence | 7-day, self-reported and verified cigarette abstinence. | Month 1 | |
Secondary | Treatment Engagement | Percentages of participants who use cessation medications and participate in counseling post discharge | Month 1 | |
Secondary | Default-theory Based Measures | We will assess the impact of opt-out versus opt-in treatment on perceived treatment coercion using items adapted from the Admission Experience Survey (AES) short form. | Month 1 | |
Secondary | 7-day Point-prevalence Abstinence | 7-day, self-reported and verified cigarette abstinence. | Month 6 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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