PRecision Interventions for SMoking in the SCCS (PRISM-SCCS)

Developing Precision Smoking Treatment in the Southern Community Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Cessation
• Intervention / Treatment: Drug: Varenicline; Drug: Nicotine patch; Behavioral: NCI "Clearing the Air"; Genetic: Nicotine metabolism; Genetic: Genetically-informed lung cancer risk score

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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Drug: Varenicline; FDA-approved smoking cessation pharmacotherapy; Other Names: Chantix; Drug: Nicotine patch; FDA-approved smoking cessation pharmacotherapy; Other Names: Nicotine Replacement Therapy; Behavioral: 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.
Active Comparator: Nicotine Metabolite Ratio (PC-NMR); Group 1, nicotine metabolism. Medication is guided by nicotine metabolism.	Drug: Varenicline; FDA-approved smoking cessation pharmacotherapy; Other Names: Chantix; Drug: Nicotine patch; FDA-approved smoking cessation pharmacotherapy; Other Names: Nicotine Replacement Therapy; Behavioral: 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.; Genetic: Nicotine metabolism; Information on nicotine metabolism will be used to inform selection of medication.
Active Comparator: 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.	Drug: Varenicline; FDA-approved smoking cessation pharmacotherapy; Other Names: Chantix; Drug: Nicotine patch; FDA-approved smoking cessation pharmacotherapy; Other Names: Nicotine Replacement Therapy; Behavioral: 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.; Genetic: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Feasibility: Ability to Retain Participants	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.	Full trial: Baseline - 6 month survey

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cessation History - Quit Attempts	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	Full trial: Baseline - 6 month survey
Cessation History - Medication Use	Participants who received, and those who subsequently used, a smoking cessation medication during the trial	Full trial: Baseline - 6 month survey
Cessation History - Quitline	Participants who reported using the quitline ("phone support") at any point during the trial	Full trial: Baseline - 6 month survey
Cessation History - Self-reported Abstinence	Participants who self-reported abstinence at the 6 month survey	6 months
Cessation History - Validated Abstinence	Participants who completed a salivary cotinine sample; participants who biochemically-verified as abstinent (salivary cotinine ≤10ng/ml)	6 months

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: Meharry Medical College; Tennessee State University
• Investigators: Principal Investigator: Hilary A Tindle, MD, MPH, Vanderbilt University Medical Center; Principal Investigator: Maureen Sanderson, PhD, RD, MPH, Meharry Medical College; Principal Investigator: Rebecca Selove, PhD, MPH, Tennessee State University; Principal Investigator: William Blot, PhD, Southern Community Cohort Study, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2018
• Primary Completion (Actual): April 11, 2019
• Study Completion (Actual): April 25, 2019

Study Registration Dates

• First Submitted: April 27, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Precision Medicine; Tobacco Use Cessation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine; Varenicline
• Other Study ID Numbers: 160331; 16-06-571 (Other Identifier: Meharry Medical College); HS2016-3815 (Other Identifier: Tennessee State University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data (IPD) available to other researchers or institutions.

Drug and device information, study documents

• 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.: Yes