Smoking Cessation Clinical Trial
Official title:
Reducing Tobacco Related Health Disparities
The goal of this research study is to learn the effectiveness of telephone-based counseling on helping smokers change their smoking patterns.
Status | Completed |
Enrollment | 639 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. HCHD Patient or is at or below 200% of the poverty guideline 2. 18 years of age or older 3. Current smoker 4. History of at least one cigarette per day for the past year 5. Not ready to quit in the next 30 days 6. Valid home address 7. Functioning telephone number 8. Can speak, read, and understand English 9. Register "5" or more on a carbon monoxide breath test Exclusion Criteria: 1. Other household members enrolled in this study 2. Enrolled in any other smoking study during the past 90 days 3. Scores below the 6th grade literacy level on the Rapid Estimate of Adult Literacy in Medicine (REALM) 4. Regular use of tobacco products other than cigarettes 5. Pregnancy or lactation 6. Active substance dependence (exclusive of nicotine dependence) 7. Use of bupropion or nicotine products |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients with Tobacco Abstinence | Prolonged abstinence refers to abstinence beginning with initiation of the intervention and including a grace period. Prolonged abstinence measure utilizes the Society for Research on Nicotine and Tobacco's recommendation for determining relapse (i.e., 7 consecutive days of smoking or smoking in each of 2 consecutive weeks). Abstinence at all follow-ups will be biochemically verified using a carbon monoxide level of <10ppm. Saliva samples collected for cotinine tests at the baseline and 24 month follow-up visits. Saliva samples analyzed for cotinine, a metabolic byproduct of nicotine that provides an estimate of nicotine consumption. A saliva cotinine level of <20 ng/ml considered as abstinent. | 24 months | No |
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