Clinical trial NCT03521141: PRecision Interventions for SMoking in the SCCS
Official title: Developing Precision Smoking Treatment in the Southern Community Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Tobacco Use Cessation
Keywords: Tobacco Use Cessation
Precision Medicine
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Meharry Medical College
name: Tennessee State University
First posted: 2018-05-11
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assessing parallel precision care interventions (groups 1, 2) and control group.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Intervention Feasibility: Ability to Retain Participants
timeFrame: Full trial: Baseline - 6 month survey
Secondary outcomes:
measure: Cessation History - Quit Attempts
timeFrame: Full trial: Baseline - 6 month survey
measure: Cessation History - Medication Use
timeFrame: Full trial: Baseline - 6 month survey
measure: Cessation History - Quitline
timeFrame: Full trial: Baseline - 6 month survey
measure: Cessation History - Self-reported Abstinence
timeFrame: 6 months
measure: Cessation History - Validated Abstinence
timeFrame: 6 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Hilary A Tindle, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Meharry Medical College
name: Maureen Sanderson, PhD, RD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Tennessee State University
name: Rebecca Selove, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Southern Community Cohort Study, Vanderbilt University Medical Center
name: William Blot, PhD
role: PRINCIPAL_INVESTIGATOR
References: