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Individualizing Pharmacotherapy for African American Smokers

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ClinicalTrials.gov Identifier: NCT03897439
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : May 6, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Nikki Nollen, PhD, MA, University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Nicotine patch Drug: Varenicline Tartrate Drug: Bupropion Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 392 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Individualizing Pharmacotherapy: A Novel Optimization Strategy to Increase Smoking Cessation in the African American Community
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : May 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Usual Care (UC)
196 African American smokers will receive 12 weeks of smoking cessation counseling and 18 weeks of nicotine patch.
Drug: Nicotine patch
Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.
Other Name: Nicoderm

Experimental: Optimized Care (OPT)
196 African American smokers will receive 12 weeks of smoking cessation counseling. They will receive the nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified smoking status at Weeks 2 and 6 for a total of 18 weeks of pharmacotherapy.
Drug: Nicotine patch
Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.
Other Name: Nicoderm

Drug: Varenicline Tartrate
VAR will be dispensed 0.5 mg once daily on Days 1-3, 0.5 mg twice daily on Days 4-7, and 1 mg twice daily from Day 8 through the end of treatment.
Other Name: Chantix

Drug: Bupropion
BUP will be dispensed 150 mg once daily on Days 0-3 and then 150 mg twice daily from Day 4 through optimization or the end of treatment.
Other Names:
  • Zyban
  • Wellbutrin




Primary Outcome Measures :
  1. Biochemically verified smoking abstinence [ Time Frame: 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.


Secondary Outcome Measures :
  1. Biochemically verified smoking abstinence [ Time Frame: 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

  2. Biochemically verified smoking abstinence [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897439


Contacts
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Contact: Tricia Snow 816-599-5311 psnow@kumc.edu
Contact: Nicole Nollen, PhD

Locations
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United States, Missouri
Swope Health Central Recruiting
Kansas City, Missouri, United States, 64130
Contact: Tricia Snow    816-599-5311    psnow@kumc.edu   
Sponsors and Collaborators
University of Kansas Medical Center
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Nicole Nollen, PhD University of Kansas Medical Center

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Responsible Party: Nikki Nollen, PhD, MA, Associate Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03897439     History of Changes
Other Study ID Numbers: Study0000142310
R01DA046576 ( U.S. NIH Grant/Contract )
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Bupropion
Nicotine
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors