Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
67 participants
INTERVENTIONAL
2018-05-18
2019-04-25
Brief Summary
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Detailed Description
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Tennessee and Mississippi Smokers that responded to a previous survey indicating willingness to be contacted for a smoking cessation clinical trial will be assessed for eligibility via phone and, if eligible, provide verbal consent and administer a baseline survey. These participants will then mail in written consent, upon receipt of which their SCCS stored blood samples will be analyzed. During lab processing, a study tobacco counselor will call enrolled participants to assist with their quit plan and inform them of randomization status. Participants will complete telephone surveys at 1, 3, and 6 months. During the 6 month follow-up call, participants will also be given their previously-unreported lab results (i.e., information on nicotine metabolism or lung cancer risk). After receiving lab results, participants will complete a final brief questionnaire.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Guideline-Based Care (GBC)
GBC participants are 1) referred to the state quitline, 2) provided the NCI Clearing the Air smoking cessation program, and 3) asked to talk to their healthcare provider about potential lung cancer screening (LCS). Medication assignment is guided by standard guidelines and a conversation between the study tobacco counselor and the participant. Groups 1 and 2 also receive GBC counseling.
Nicotine patch
FDA-approved smoking cessation pharmacotherapy
Varenicline
FDA-approved smoking cessation pharmacotherapy
NCI "Clearing the Air"
A booklet-led intervention designed by the NCI to support cessation at any stage of a quitter's journey, whether they are still thinking about quitting, have made the decision to quit, or have already taken steps to quit and just need help maintaining their new lifestyle.
Nicotine Metabolite Ratio (PC-NMR)
Group 1, nicotine metabolism. Medication is guided by nicotine metabolism.
Nicotine patch
FDA-approved smoking cessation pharmacotherapy
Varenicline
FDA-approved smoking cessation pharmacotherapy
Nicotine metabolism
Information on nicotine metabolism will be used to inform selection of medication.
NCI "Clearing the Air"
A booklet-led intervention designed by the NCI to support cessation at any stage of a quitter's journey, whether they are still thinking about quitting, have made the decision to quit, or have already taken steps to quit and just need help maintaining their new lifestyle.
Respiragene (PC-Respiragene)
Group 2, genetically-informed lung cancer risk score. Medication assignment is guided by standard guidelines and a conversation between the study nurse and the participant.
Nicotine patch
FDA-approved smoking cessation pharmacotherapy
Varenicline
FDA-approved smoking cessation pharmacotherapy
Genetically-informed lung cancer risk score
This intervention uses information from a person's genes and smoking and family medical histories to estimate lung cancer risk compared to current smokers.
NCI "Clearing the Air"
A booklet-led intervention designed by the NCI to support cessation at any stage of a quitter's journey, whether they are still thinking about quitting, have made the decision to quit, or have already taken steps to quit and just need help maintaining their new lifestyle.
Interventions
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Nicotine patch
FDA-approved smoking cessation pharmacotherapy
Varenicline
FDA-approved smoking cessation pharmacotherapy
Nicotine metabolism
Information on nicotine metabolism will be used to inform selection of medication.
Genetically-informed lung cancer risk score
This intervention uses information from a person's genes and smoking and family medical histories to estimate lung cancer risk compared to current smokers.
NCI "Clearing the Air"
A booklet-led intervention designed by the NCI to support cessation at any stage of a quitter's journey, whether they are still thinking about quitting, have made the decision to quit, or have already taken steps to quit and just need help maintaining their new lifestyle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Enrolled participant of the Southern Community Cohort Study (SCCS) who completed a prior survey indicating they were willing to be contacted regarding a smoking cessation clinical trial
* Residence in Tennessee (TN) or Mississippi (MS)
* Has stored blood sample with the SCCS
* Has established primary care provider (PCP)
* Medically eligible and willing to take varenicline and NRT
Exclusion Criteria
* enrolled, or planning to be enrolled, in another smoking cessation program
* Inability to give informed consent or participate due to cognitive disorder (e.g., dementia, severe intellectual disability)
* Unstable psychiatric illness (ER or hospitalized for psychiatric condition in past 6 months, change in psychiatric medications in past 3 months, or suicidal ideation in past 6 months)
* not able to send or receive mail
* no access to a telephone or inability to communicate by telephone
* unable to speak and read English
* history of seizures or Buerger's disease
* currently pregnant or breastfeeding
18 Years
ALL
No
Sponsors
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Meharry Medical College
OTHER
Tennessee State University
OTHER
Vanderbilt University Medical Center
OTHER
Responsible Party
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Hilary Tindle
Associate Professor of Medicine
Principal Investigators
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Hilary A Tindle, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Maureen Sanderson, PhD, RD, MPH
Role: PRINCIPAL_INVESTIGATOR
Meharry Medical College
Rebecca Selove, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Tennessee State University
William Blot, PhD
Role: PRINCIPAL_INVESTIGATOR
Southern Community Cohort Study, Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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References
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Lee SS, Senft Everson N, Sanderson M, Selove R, Blot WJ, King S, Gilliam K, Kundu S, Steinwandel M, Sternlieb SJ, Cai Q, Warren Andersen S, Friedman DL, Connors Kelly E, Fadden MK, Freiberg MS, Wells QS, Canedo J, Tyndale RF, Young RP, Hopkins RJ, Tindle HA. Feasibility of precision smoking treatment in a low-income community setting: results of a pilot randomized controlled trial in The Southern Community Cohort Study. Addict Sci Clin Pract. 2024 Mar 15;19(1):16. doi: 10.1186/s13722-024-00441-1.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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16-06-571
Identifier Type: OTHER
Identifier Source: secondary_id
HS2016-3815
Identifier Type: OTHER
Identifier Source: secondary_id
160331
Identifier Type: -
Identifier Source: org_study_id
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