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

Vanderbilt University Medical Center

Status and phase: Completed; Phase 3; Phase 2

Conditions: Tobacco Use Cessation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03521141

160331

HS2016-3815 (Other Identifier)

16-06-571 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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67 participants in 3 patient groups

Guideline-Based Care (GBC)

Other group

Description:

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.

Treatment:

Drug: Varenicline

Behavioral: NCI "Clearing the Air"

Drug: Nicotine patch

Nicotine Metabolite Ratio (PC-NMR)

Active Comparator group

Description:

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

Treatment:

Drug: Varenicline

Behavioral: NCI "Clearing the Air"

Genetic: Nicotine metabolism

Drug: Nicotine patch

Respiragene (PC-Respiragene)

Active Comparator group

Description:

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.

Treatment:

Drug: Varenicline

Behavioral: NCI "Clearing the Air"

Drug: Nicotine patch

Genetic: Genetically-informed lung cancer risk score