Tobacco Use, Tobacco Use Cessation
Conditions
Keywords
Personalized Medicine, Nicotine Metabolite Ratio (NMR), Varenicline, Nicotine Replacement Therapy (NRT), Smoking Cessation, Pharmacotherapy
Brief summary
Nicotine mediates smoking's addictive effects in the brain. The ratio of 3-hydroxycotinine to cotinine, known as the nicotine metabolite ratio, or NMR, is a genetically- informed biomarker reflecting hepatic CYP2A6 activity and the rate of nicotine metabolism. In light of a recent randomized controlled trial (RCT) in humans in Lancet Respiratory Medicine, which found that the NMR can be used to individualize treatment for smokers, our pilot study aims to determine the feasibility of using NMR to guide selection of pharmacotherapy in clinical populations of daily smokers.
Detailed description
Consenting participants will be assigned to guideline-based care (GBC: incorporating national guidelines and more recent evidence from clinical trials of pharmacotherapy for smoking cessation) or metabolism-informed care (MIC: identical to GBC but selection of medication based on NMR result). All participants received counseling from a nurse level certified tobacco counseling. After consent, participants undergo a blood draw for NMR, complete a baseline questionnaire, and are randomized to GBC or MIC. At approximately 1, 3, and 6 months post-consent, participants will provide follow up information via telephone questionnaire regarding symptoms, confidence in quitting, use of medications, and smoking status. At the 6-month follow-up time point, if a participant self-reports abstinence from smoking, the participant will be asked to complete a survey in-person and provide a sample of end-expired carbon monoxide for biochemical validation. At the 6 month time point, GBC participants who continue to smoke will be offered an additional phone call from the nurse tobacco counselor in which the results of the baseline NMR test will be given, along with a second prescription for a smoking cessation medication based on the NMR results (i.e., single arm crossover design). Two weeks after this additional phone call, the patient will be contacted for a final survey regarding use of medication and smoking status.
Interventions
This intervention used information from a genetically-informed biomarker (Nicotine Metabolite Ratio, NMR) to assign one of 3 FDA-approved smoking cessation pharmacotherapies (varenicline, bupropion, or NRT) to participants.
DRUGVarenicline
FDA-approved smoking cessation pharmacotherapy
DRUGBupropion
FDA-approved smoking cessation pharmacotherapy
DRUGNicotine patch
FDA-approved smoking cessation pharmacotherapy
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Participant, Nurse, and RAs all blinded to random Arm assignment, none blinded to medication prescription
Intervention model description
Parallel arm pilot trial with a single-arm crossover design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Smokes ≥ 5 cigarettes per day * Willing to give up all forms of tobacco (5/10/2016 - 6/27/2016) * Medically cleared (i.e., no contraindications in Section 3) to receive at least 2 FDA- approved smoking cessation medications * Willing to use the medications for which medically cleared (individually, not in combination; only applicable if Medically Cleared = Yes)
Exclusion criteria
* Current diagnosis of schizophrenia, psychosis, active suicidal ideation, dementia, or severe mental retardation * Receiving palliative or hospice care * Currently pregnant or breastfeeding * Hospitalized for a psychiatric condition in the past year (5/10/2016 - 6/27/2016) * Hospitalized for a psychiatric condition in the past 3 months or change in psychiatric medications in last 3 months (6/28/2016 forward) * Telephone problems that would preclude participation (e.g., can't receive calls reliably) * Not able to read and speak English * Abstinent from cigarettes for \>3 days (b/c NMR not reliable after 72 hours) * Used smoking cessation medications in the last 7 days (5/10/2016 - 6/27/2016)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Theoretical Endorsement of MIC as assessed by level of agreement to a set of seven 5-point Likert Scale questions | Baseline | Likert Scale from Strongly Disagree to Strongly Agree on items assessing attitudes toward and perceptions of using metabolism information to guide medical care |
| Acceptance of MIC medication recommendation as assessed by concordance between MIC recommendation and actual prescribed medication | At 4 weeks post-baseline | Level of agreement between participant's prescribed medication and the medication that would be recommended based on Nicotine Metabolite Ratio |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Confidence in Quitting | Baseline - 6 months | Self-reported confidence in ability to quit |
| Medication Use/Compliance | 1 - 6 months | Use of prescribed medication, as directed |
| Smoking Status | 6 months | Self-reported and/or biochemically validated smoking cessation |
Outcome results
None listed