Tobacco Use Cessation
Conditions
Keywords
Tobacco Use Cessation, Precision Medicine
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.
Interventions
DRUGNicotine patch
FDA-approved smoking cessation pharmacotherapy
DRUGVarenicline
FDA-approved smoking cessation pharmacotherapy
GENETICNicotine metabolism
Information on nicotine metabolism will be used to inform selection of medication.
GENETICGenetically-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.
BEHAVIORALNCI 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.
Sponsors
Meharry Medical College
Tennessee State University
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors will be blind to participant arm assignment until delivery of lab results at month 6.
Intervention model description
Assessing parallel precision care interventions (groups 1, 2) and control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Feasibility: Ability to Retain Participants | Full trial: Baseline - 6 month survey | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cessation History - Quit Attempts | Full trial: Baseline - 6 month survey | 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 |
| Cessation History - Medication Use | Full trial: Baseline - 6 month survey | Participants who received, and those who subsequently used, a smoking cessation medication during the trial |
| Cessation History - Quitline | Full trial: Baseline - 6 month survey | Participants who reported using the quitline (phone support) at any point during the trial |
| Cessation History - Self-reported Abstinence | 6 months | Participants who self-reported abstinence at the 6 month survey |
| Cessation History - Validated Abstinence | 6 months | Participants who completed a salivary cotinine sample; participants who biochemically-verified as abstinent (salivary cotinine ≤10ng/ml) |
Countries
United States
Participant flow
Recruitment details
Mailed and Phone outreach to enrolled SCCS participants.
Pre-assignment details
Begin enrollment (Baseline survey) for verbal consent, randomize on receipt of written consent. Analysis performed on randomized participants who completed the Results Call (those who began the pilot trial).
Participants by arm
| Arm | Count |
|---|---|
| Guideline-Based Care (GBC) 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.
Nicotine patch: FDA-approved smoking cessation pharmacotherapy
Varenicline: FDA-approved smoking cessation pharmacotherapy
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. | 19 |
| Nicotine Metabolite Ratio (PC-NMR) Group 1, nicotine metabolism. Medication is guided by nicotine metabolism.
Nicotine patch: FDA-approved smoking cessation pharmacotherapy
Varenicline: FDA-approved smoking cessation pharmacotherapy
Nicotine metabolism: Information on nicotine metabolism will be used to inform selection of medication.
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. | 19 |
| Respiragene (PC-Respiragene) 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.
Nicotine patch: FDA-approved smoking cessation pharmacotherapy
Varenicline: FDA-approved smoking cessation pharmacotherapy
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.
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. | 20 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Guideline-Based Care (GBC) | Total | Respiragene (PC-Respiragene) | Nicotine Metabolite Ratio (PC-NMR) |
|---|---|---|---|---|
| Age, Continuous | 59.49 years | 59.24 years | 57.92 years | 62.23 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 58 Participants | 20 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 47 Participants | 17 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 10 Participants | 2 Participants | 5 Participants |
| Region of Enrollment United States | 19 participants | 58 participants | 20 participants | 19 participants |
| Sex: Female, Male Female | 15 Participants | 42 Participants | 13 Participants | 14 Participants |
| Sex: Female, Male Male | 4 Participants | 16 Participants | 7 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 19 | 0 / 19 | 1 / 20 |
| other Total, other adverse events | 19 / 19 | 18 / 19 | 17 / 20 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 | 0 / 20 |
Outcome results
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.
Time frame: Full trial: Baseline - 6 month survey
Population: Randomized participants who completed the Results Call, allowing for the intervention to be assigned and begin
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Guideline-Based Care (GBC) | Intervention Feasibility: Ability to Retain Participants | Still enrolled at end of pilot trial | 18 Participants |
| Guideline-Based Care (GBC) | Intervention Feasibility: Ability to Retain Participants | Started Pilot Trial (completed results call) | 19 Participants |
| Guideline-Based Care (GBC) | Intervention Feasibility: Ability to Retain Participants | Completed 6 month survey | 17 Participants |
| Nicotine Metabolite Ratio (PC-NMR) | Intervention Feasibility: Ability to Retain Participants | Still enrolled at end of pilot trial | 18 Participants |
| Nicotine Metabolite Ratio (PC-NMR) | Intervention Feasibility: Ability to Retain Participants | Started Pilot Trial (completed results call) | 19 Participants |
| Nicotine Metabolite Ratio (PC-NMR) | Intervention Feasibility: Ability to Retain Participants | Completed 6 month survey | 14 Participants |
| Respiragene (PC-Respiragene) | Intervention Feasibility: Ability to Retain Participants | Started Pilot Trial (completed results call) | 20 Participants |
| Respiragene (PC-Respiragene) | Intervention Feasibility: Ability to Retain Participants | Completed 6 month survey | 12 Participants |
| Respiragene (PC-Respiragene) | Intervention Feasibility: Ability to Retain Participants | Still enrolled at end of pilot trial | 19 Participants |
Secondary
Cessation History - Medication Use
Participants who received, and those who subsequently used, a smoking cessation medication during the trial
Time frame: Full trial: Baseline - 6 month survey
Population: Randomized participants who completed the Results Call, and were enrolled in the study through the 6 month timepoint (i.e., not withdrawn nor deceased)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Guideline-Based Care (GBC) | Cessation History - Medication Use | Received any cessation medication | 17 Participants |
| Guideline-Based Care (GBC) | Cessation History - Medication Use | Started/used any cessation medication | 14 Participants |
| Nicotine Metabolite Ratio (PC-NMR) | Cessation History - Medication Use | Received any cessation medication | 15 Participants |
| Nicotine Metabolite Ratio (PC-NMR) | Cessation History - Medication Use | Started/used any cessation medication | 9 Participants |
| Respiragene (PC-Respiragene) | Cessation History - Medication Use | Received any cessation medication | 16 Participants |
| Respiragene (PC-Respiragene) | Cessation History - Medication Use | Started/used any cessation medication | 14 Participants |
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
Time frame: Full trial: Baseline - 6 month survey
Population: Randomized participants who completed the Results Call, and were enrolled in the study through the 6 month timepoint (i.e., not withdrawn nor deceased)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Guideline-Based Care (GBC) | Cessation History - Quit Attempts | 16 Participants |
| Nicotine Metabolite Ratio (PC-NMR) | Cessation History - Quit Attempts | 17 Participants |
| Respiragene (PC-Respiragene) | Cessation History - Quit Attempts | 17 Participants |
Secondary
Cessation History - Quitline
Participants who reported using the quitline (phone support) at any point during the trial
Time frame: Full trial: Baseline - 6 month survey
Population: Randomized participants who completed the Results Call, and were enrolled in the study through the 6 month timepoint (i.e., not withdrawn nor deceased)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Guideline-Based Care (GBC) | Cessation History - Quitline | 4 Participants |
| Nicotine Metabolite Ratio (PC-NMR) | Cessation History - Quitline | 5 Participants |
| Respiragene (PC-Respiragene) | Cessation History - Quitline | 5 Participants |
Secondary
Cessation History - Self-reported Abstinence
Participants who self-reported abstinence at the 6 month survey
Time frame: 6 months
Population: Randomized participants who completed the Results Call, and were enrolled in the study through the 6 month timepoint (i.e., not withdrawn nor deceased)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Guideline-Based Care (GBC) | Cessation History - Self-reported Abstinence | 7 Participants |
| Nicotine Metabolite Ratio (PC-NMR) | Cessation History - Self-reported Abstinence | 5 Participants |
| Respiragene (PC-Respiragene) | Cessation History - Self-reported Abstinence | 3 Participants |
Secondary
Cessation History - Validated Abstinence
Participants who completed a salivary cotinine sample; participants who biochemically-verified as abstinent (salivary cotinine ≤10ng/ml)
Time frame: 6 months
Population: Randomized participants who completed the Results Call, and were enrolled in the study through the 6 month timepoint (i.e., not withdrawn nor deceased)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Guideline-Based Care (GBC) | Cessation History - Validated Abstinence | Salivary cotinine sample received by study staff | 5 Participants |
| Guideline-Based Care (GBC) | Cessation History - Validated Abstinence | Validated as abstinent (cotinine ≤10ng/ml) | 3 Participants |
| Nicotine Metabolite Ratio (PC-NMR) | Cessation History - Validated Abstinence | Salivary cotinine sample received by study staff | 3 Participants |
| Nicotine Metabolite Ratio (PC-NMR) | Cessation History - Validated Abstinence | Validated as abstinent (cotinine ≤10ng/ml) | 2 Participants |
| Respiragene (PC-Respiragene) | Cessation History - Validated Abstinence | Salivary cotinine sample received by study staff | 3 Participants |
| Respiragene (PC-Respiragene) | Cessation History - Validated Abstinence | Validated as abstinent (cotinine ≤10ng/ml) | 2 Participants |