Skip to main content
OpenTrials
Completed

NCT Number: NCT03521141

PRecision Interventions for SMoking in the SCCS

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tobacco Use Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotine patch

Drug

FDA-approved smoking cessation pharmacotherapy

Other names: Nicotine Replacement Therapy

Varenicline

Drug

FDA-approved smoking cessation pharmacotherapy

Other names: Chantix

Nicotine metabolism

Genetic

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

Genetically-informed lung cancer risk score

Genetic

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"

Behavioral

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.

Primary outcomes

  1. Intervention Feasibility: Ability to Retain Participants

    Time frame: 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 outcomes

  1. Cessation History - Quit Attempts

    Time frame: 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

  2. Cessation History - Medication Use

    Time frame: Full trial: Baseline - 6 month survey

    Participants who received, and those who subsequently used, a smoking cessation medication during the trial

  3. Cessation History - Quitline

    Time frame: Full trial: Baseline - 6 month survey

    Participants who reported using the quitline ("phone support") at any point during the trial

  4. Cessation History - Self-reported Abstinence

    Time frame: 6 months

    Participants who self-reported abstinence at the 6 month survey

  5. Cessation History - Validated Abstinence

    Time frame: 6 months

    Participants who completed a salivary cotinine sample; participants who biochemically-verified as abstinent (salivary cotinine ≤10ng/ml)

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Meharry Medical College
  • Tennessee State University

Registry information

Official study title

Developing Precision Smoking Treatment in the Southern Community Cohort Study

Acronym: PRISM-SCCS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 11, 2018
Registry last updated
Jun 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.