PRecision Interventions for SMoking in the SCCS

NCT03521141 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: 16033116-06-571HS2016-3815
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Cessation

Keywords

Tobacco Use Cessation; Precision Medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Cessation History - Quit Attempts

  Full trial: Baseline - 6 month survey

• Cessation History - Medication Use

  Full trial: Baseline - 6 month survey

• Cessation History - Quitline

  Full trial: Baseline - 6 month survey

• Cessation History - Self-reported Abstinence

  6 months

• Cessation History - Validated Abstinence

  6 months

Study Arms (3)

Guideline-Based Care (GBC)

OTHER

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: Nicotine patch; Drug: Varenicline; Behavioral: NCI "Clearing the Air"

Nicotine Metabolite Ratio (PC-NMR)

ACTIVE COMPARATOR

Group 1, nicotine metabolism. Medication is guided by nicotine metabolism.

Drug: Nicotine patch; Drug: Varenicline; Genetic: Nicotine metabolism; Behavioral: NCI "Clearing the Air"

Respiragene (PC-Respiragene)

ACTIVE COMPARATOR

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

Interventions

Nicotine patch DRUG

FDA-approved smoking cessation pharmacotherapy

Also known as: Nicotine Replacement Therapy

Guideline-Based Care (GBC); Nicotine Metabolite Ratio (PC-NMR); Respiragene (PC-Respiragene)

Varenicline DRUG

FDA-approved smoking cessation pharmacotherapy

Also known as: Chantix

Guideline-Based Care (GBC); Nicotine Metabolite Ratio (PC-NMR); Respiragene (PC-Respiragene)

Nicotine metabolism GENETIC

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

Nicotine Metabolite Ratio (PC-NMR)

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.

Respiragene (PC-Respiragene)

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.

Guideline-Based Care (GBC); Nicotine Metabolite Ratio (PC-NMR); Respiragene (PC-Respiragene)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Meharry Medical College: collaborator
• Tennessee State University: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• 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.

  PMID: 38491559 DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation

Interventions

Tobacco Use Cessation Devices; Nicotine Replacement Therapy; Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Drug Therapy; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Limitations and Caveats

Due to the small sample size of this pilot feasibility study, we cannot draw conclusions about differences across study arms. Larger follow-up studies are needed to test the efficacy of these precision approaches compared to guideline based care.

Results Point of Contact

• Title: Stephen King
• Organization: Vanderbilt University Medical Center

stephen.king@vumc.org

615-875-9394

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blind to participant arm assignment until delivery of lab results at month 6.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Assessing parallel precision care interventions (groups 1, 2) and control group.

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 11, 2018
• Study Start: May 18, 2018
• Primary Completion: April 11, 2019
• Study Completion: April 25, 2019
• Last Updated: June 1, 2020
• Results First Posted: June 1, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)