Clinical trial NCT03897439: Individualizing Pharmacotherapy for African American Smokers
Official title: Individualizing Pharmacotherapy: A Novel Optimization Strategy to Increase Smoking Cessation in the African American Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-04-01
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.

African American smokers randomized to enhanced UC (n=196) will receive the same high intensity counseling and NP with no optimizations in pharmacotherapy.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The objective of this study is to examine the efficacy of optimized (OPT) versus enhanced usual care (UC) treatment for smoking cessation. 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. African American smokers randomized to enhanced UC (n=196) will receive the same high intensity counseling and NP with no optimizations in pharmacotherapy. Pharmacotherapy and counseling in both groups will last for 18 weeks with long-term follow-up through Week 26. The primary outcome is biochemically-verified smoking status at Week 12.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Biochemically Verified Smoking Abstinence at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Number of Participants With Biochemically Verified Smoking Abstinence at Week 18
timeFrame: Week 18
measure: Number of Participants With Biochemically Verified Smoking Abstinence at Week 26
timeFrame: Week 26
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Swope Health Central
state: Missouri
Study officials:
affiliation: University of Kansas Medical Center
name: Nicole Nollen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nollen NL, Cox LS, Mayo MS, Ellerbeck EF, Arnold MJ, Salzman G, Shanks D, Woodward J, Greiner KA, Ahluwalia JS. Protocol from a randomized clinical trial of multiple pharmacotherapy adaptations based on treatment response in African Americans who smoke. Contemp Clin Trials Commun. 2022 Nov 5;30:101032. doi: 10.1016/j.conctc.2022.101032. eCollection 2022 Dec.