Smoking Cessation Clinical Trial
Official title:
Individualizing Pharmacotherapy: A Novel Optimization Strategy to Increase Smoking Cessation in the African American Community
Verified date | March 2023 |
Source | University of Kansas Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Improving cessation outcomes for African American smokers through the use of novel, empirically-based strategies is a national health priority. In the vast majority of smoking cessation studies and in clinical practice, when smokers are provided a medication to help them quit, they are expected to continue that medication regardless of how well it is working. This study will assess whether African Americans smokers respond better if they continue with a single treatment or if their treatment is changed when that treatment is not working.
Status | Completed |
Enrollment | 392 |
Est. completion date | January 30, 2022 |
Est. primary completion date | November 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Non-Hispanic African American - = 18 years of age - Smoke 5-30 cigarettes per day (CPD) - Daily cigarette smoker - Smoked at current rate for > 6 months - Verified smoker (CO > 5 ppm) - Functioning telephone - Interested in quitting smoking - Willing to take NP, VAR , and/or BUP+NP for 18 weeks and complete all study visits Exclusion Criteria: - Use of non-cigarette tobacco products in past 30 days - Medical contraindications to NP, BUP, or VAR: unstable cardiac condition (e.g., unstable angina or AMI) cardiac event, or stroke in the past 4 weeks; renal impairment; medications contraindicated ; history of clinically significant allergic reactions; history of epilepsy, seizure, head trauma, psychosis, bipolar disorder, eating disorder; unstable panic disorder or depression; active suicidal ideation; treatment for alcohol or drug dependence in the past year - Use of pharmacotherapy in the month prior to enrollment - Pregnant, contemplating getting pregnant, or breastfeeding - Unstable housing (e.g., street, shelter) - Plans to move from Kansas City during the treatment and follow-up phase - Another household member enrolled in the study |
Country | Name | City | State |
---|---|---|---|
United States | Swope Health Central | Kansas City | Missouri |
Lead Sponsor | Collaborator |
---|---|
University of Kansas Medical Center | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Biochemically Verified Smoking Abstinence at Week 12 | Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 12 visit. This will evaluate the short-term efficacy of optimized pharmacotherapy for smoking cessation in African American smokers. | Week 12 | |
Secondary | Number of Participants With Biochemically Verified Smoking Abstinence at Week 18 | Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 18 visit. This will evaluate the end-of-treatment efficacy of optimized pharmacotherapy for smoking cessation in African American smokers | Week 18 | |
Secondary | Number of Participants With Biochemically Verified Smoking Abstinence at Week 26 | Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 26 visit. This will evaluate the long-term efficacy of optimized pharmacotherapy for smoking cessation in African American smokers | Week 26 |
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