PRecision Interventions for SMoking in the SCCS

Tobacco Use Cessation Clinical Trial

— PRISM-SCCS  

Official title:

Developing Precision Smoking Treatment in the Southern Community Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03521141
• Other study ID #: 160331
• Secondary ID: 16-06-571HS2016-
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 18, 2018
• Est. completion date: April 25, 2019

Study information

• Verified date: May 2020
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 25, 2019
• Est. primary completion date: April 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Cessation

Intervention

Drug:
• Nicotine patch
FDA-approved smoking cessation pharmacotherapy
• Varenicline
FDA-approved smoking cessation pharmacotherapy

Genetic:
• Nicotine metabolism
Information on nicotine metabolism will be used to inform selection of medication.
• Genetically-informed lung cancer risk score
This intervention uses information from a person's genes and smoking and family medical histories to estimate lung cancer risk compared to current smokers.

Behavioral:
• NCI "Clearing the Air"
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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Meharry Medical College, Tennessee State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cessation History - Quit Attempts	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	Full trial: Baseline - 6 month survey
Secondary	Cessation History - Medication Use	Participants who received, and those who subsequently used, a smoking cessation medication during the trial	Full trial: Baseline - 6 month survey
Secondary	Cessation History - Quitline	Participants who reported using the quitline ("phone support") at any point during the trial	Full trial: Baseline - 6 month survey
Secondary	Cessation History - Self-reported Abstinence	Participants who self-reported abstinence at the 6 month survey	6 months
Secondary	Cessation History - Validated Abstinence	Participants who completed a salivary cotinine sample; participants who biochemically-verified as abstinent (salivary cotinine =10ng/ml)	6 months