PRecision Interventions for SMoking in the SCCS

• Status: Completed
• Trial end date: 2019-04-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Collaborators: Meharry Medical College; Tennessee State University
• Treatments: Nicotine; Varenicline

Criteria

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