Ignite Creation Date:
2024-05-06 @ 10:20 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03227679
Status:
COMPLETED
Last Update Posted:
2017-07-24
First Post:
2017-06-29
Brief Title:
Metabolism-informed Care for Smoking Cessation
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Metabolism-informed Care for Smoking Cessation
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nicotine mediates smokings 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None