PRecision Interventions for SMoking in the SCCS

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.

Conditions

• Tobacco Use Cessation

Interventions

DRUG

Nicotine patch

FDA-approved smoking cessation pharmacotherapy

DRUG

Varenicline

FDA-approved smoking cessation pharmacotherapy

GENETIC

Nicotine metabolism

Information on nicotine metabolism will be used to inform selection of medication.

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.

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.

Sponsors & Collaborators

• Meharry Medical College

  collaborator OTHER

• Tennessee State University

  collaborator OTHER

• Vanderbilt University Medical Center

  lead OTHER

Principal Investigators

• Hilary A Tindle, MD, MPH · Vanderbilt University Medical Center

• Maureen Sanderson, PhD, RD, MPH · Meharry Medical College

• Rebecca Selove, PhD, MPH · Tennessee State University

• William Blot, PhD · Southern Community Cohort Study, Vanderbilt University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-18

Primary Completion

2019-04-11

Completion

2019-04-25

FDA Drug

Yes

Countries

• United States

Study Locations