Status:
COMPLETED
Metabolism-informed Care for Smoking Cessation
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Tobacco Use
Tobacco Use Cessation
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 meta...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 18 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2017
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT03227679
Start Date
May 18 2016
End Date
April 18 2017
Last Update
January 6 2026
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