Smoking Cessation Clinical Trial
— tANBLOfficial title:
Assessing Telephone All Nations Breath of Life for Efficacy
This project formally test an individual, telephone-based version of the All Nations Breath of Life smoking cessation program (tANBL) for American Indians (AI) for efficacy versus an untailored comparison program (CP). The primary outcome is 7-day point prevalence abstinence from smoking cigarettes at 6 months post-baseline. Secondarily, the study examines continuous abstinence and reduction in smoking at both 6 and 12 months post-baseline, as well as demographic predictors of cessation and/or reduction.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | July 31, 2025 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age 18 or older - Self-reported American Indian - Smokes at least 1 cigarette per day - Have a home address or stable address to which we can mail program supplies - Have a stable telephone number that can be used for the purpose of the study - Willing to be followed for 12 months Exclusion Criteria: - Cannot provide a stable phone number for the purpose of the study that will be available for a minimum of 12 months - Household member already in the study |
Country | Name | City | State |
---|---|---|---|
United States | Lehigh University | Bethlehem | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Lehigh University | National Institute on Drug Abuse (NIDA), University of Kansas Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cessation | 7-day point prevalence abstinence from smoking cigarettes | 6 months | |
Secondary | Cessation | 7-day point prevalence abstinence from smoking cigarettes | 12 months | |
Secondary | Continuous Cessation | Continuous abstinence from smoking cigarettes | 6 months, 12 months | |
Secondary | Smoking Change | Change in number of cigarettes per day | 6 months, 12 months |
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