PRecision Interventions for SMoking in the SCCS

Phase 2

Completed

Conditions: Tobacco Use Cessation

Interventions: Drug: Nicotine patch
Drug: Varenicline
Genetic: Nicotine metabolism
Genetic: Genetically-informed lung cancer risk score
Behavioral: NCI "Clearing the Air"

Registration Number: NCT03521141

Lead Sponsor: Vanderbilt University Medical Center

Brief Summary: Precision Care (PC) interventions, developed with guidance from a Community Advisory Board (CAB), will be piloted in a Randomized Clinical Trial (RCT) of approximately 100 eligible, consenting daily smokers in the Southern Community Cohort Study (SCCS) who are willing to make a quit attempt with medication and who reside in TN or MS. Participants will be randomized 1:1:1 to 1 of 3 groups; (1) group one informs selection of medication with information on nicotine metabolism; (2) group two offers a genetically-informed lung cancer risk score, and (3) group 3 is Guideline-Based Care (GBC). All groups will be followed for 6 months. All RCT participants will receive FDA-approved smoking cessation medication, be referred to the shared TN/MS state quitline, and be offered the NCI "Clearing the Air" standard intervention. The primary outcome is feasibility of delivering the precision interventions in the SCCS population, as evidenced by ability to recruit, engage, and retain participants through end of study. Secondary outcomes, for which the study is not powered, will include risk perceptions, use of quit aids, lung cancer screening among those who are eligible, and smoking cessation.

Detailed Description: Cigarette smoking significantly increases the risk of cancer and improved cessation strategies are needed. Biologically-informed precision treatment could benefit smokers but is understudied.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 67

Inclusion Criteria

Daily smoker of ≥5 cigarettes per day (CPD)
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

Currently taking medication to quit smoking
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guideline-Based Care (GBC)	Nicotine patch	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 Metabolite Ratio (PC-NMR)	Nicotine metabolism	Group 1, nicotine metabolism. Medication is guided by nicotine metabolism.
Respiragene (PC-Respiragene)	Nicotine patch	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 Metabolite Ratio (PC-NMR)	NCI "Clearing the Air"	Group 1, nicotine metabolism. Medication is guided by nicotine metabolism.
Respiragene (PC-Respiragene)	Genetically-informed lung cancer risk score	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.
Respiragene (PC-Respiragene)	NCI "Clearing the Air"	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.
Guideline-Based Care (GBC)	NCI "Clearing the Air"	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 Metabolite Ratio (PC-NMR)	Nicotine patch	Group 1, nicotine metabolism. Medication is guided by nicotine metabolism.
Respiragene (PC-Respiragene)	Varenicline	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.
Guideline-Based Care (GBC)	Varenicline	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 Metabolite Ratio (PC-NMR)	Varenicline	Group 1, nicotine metabolism. Medication is guided by nicotine metabolism.

Primary Outcome Measures

Name	Time	Method
Intervention Feasibility: Ability to Retain Participants	Full trial: Baseline - 6 month survey	Feasibility of delivering precision care (PC) interventions in the Southern Community Cohort Study (SCCS), as evidenced by ability to recruit, engage, and retain participants through end of the study.

Secondary Outcome Measures

Name	Time	Method
Cessation History - Self-reported Abstinence	6 months	Participants who self-reported abstinence at the 6 month survey
Cessation History - Validated Abstinence	6 months	Participants who completed a salivary cotinine sample; participants who biochemically-verified as abstinent (salivary cotinine ≤10ng/ml)
Cessation History - Medication Use	Full trial: Baseline - 6 month survey	Participants who received, and those who subsequently used, a smoking cessation medication during the trial
Cessation History - Quitline	Full trial: Baseline - 6 month survey	Participants who reported using the quitline ("phone support") at any point during the trial
Cessation History - Quit Attempts	Full trial: Baseline - 6 month survey	Participants who reported making a quit attempt during the trial, as defined by use of a quit aid or reporting "not at all" for current smoking at any timepoint