Individualizing Pharmacotherapy: A Novel Optimization Strategy to Increase Smoking Cessation in the African American Community

Study0000142310

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.

2019-05-01

2021-11-30

2022-01-30

Completed

Early phase I

392

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'African American smokers randomized to OPT (n=196) will receive high intensity smoking cessation counseling, nicotine patch (NP), and up to two pharmacotherapy optimizations \\[varenicline (VAR), bupropion (BUP) plus NP\\] based on verified smoking status at Weeks 2 and 6.\n\nAfrican American smokers randomized to enhanced UC (n=196) will receive the same high intensity counseling and NP with no optimizations in pharmacotherapy.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 392, 'type': 'ACTUAL'}}

2023-04-03