Metabolism-informed Care for Smoking Cessation

July 20, 2017 updated by: Hilary Tindle, Vanderbilt University Medical Center
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Metabolism-Informed Care (MIC)
Smoking Cessation Pharmacotherapy (varenicline, bupropion, and nicotine patch) recommendations were guided by Nicotine Metabolism as measured by the Nicotine Metabolite Ratio. Ultimately, after being educated about smoking cessation medication efficacy and side-effects, the participant could decide to take any medication for which they were medically cleared, but the recommendation was made based on rate of Nicotine Metabolism.
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.
FDA-approved smoking cessation pharmacotherapy
Other Names:
  • Chantix
FDA-approved smoking cessation pharmacotherapy
Other Names:
  • Zyban
FDA-approved smoking cessation pharmacotherapy
Other Names:
  • Nicotine Replacement Therapy (NRT)
Active Comparator: Guideline-Based Care (GBC)
Smoking Cessation Pharmacotherapy (varenicline, bupropion, and nicotine patch) was co-selected from those they were medically able to receive after educating participants about smoking cessation medication efficacy and side-effects.
FDA-approved smoking cessation pharmacotherapy
Other Names:
  • Chantix
FDA-approved smoking cessation pharmacotherapy
Other Names:
  • Zyban
FDA-approved smoking cessation pharmacotherapy
Other Names:
  • Nicotine Replacement Therapy (NRT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Theoretical Endorsement of MIC as assessed by level of agreement to a set of seven 5-point Likert Scale questions
Time Frame: Baseline
Likert Scale from Strongly Disagree to Strongly Agree on items assessing attitudes toward and perceptions of using metabolism information to guide medical care
Baseline
Acceptance of MIC medication recommendation as assessed by concordance between MIC recommendation and actual prescribed medication
Time Frame: 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
At 4 weeks post-baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confidence in Quitting
Time Frame: Baseline - 6 months
Self-reported confidence in ability to quit
Baseline - 6 months
Medication Use/Compliance
Time Frame: 1 - 6 months
Use of prescribed medication, as directed
1 - 6 months
Smoking Status
Time Frame: 6 months
Self-reported and/or biochemically validated smoking cessation
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Quinn Wells, MD, Vanderbilt University Medical Center
  • Principal Investigator: Dawn Beaulieu, MD, Vanderbilt University Medical Center
  • Principal Investigator: Matthew Freiberg, MD, Vanderbilt University Medical Center
  • Principal Investigator: Hilary Tindle, MD, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2016

Primary Completion (Actual)

October 8, 2016

Study Completion (Actual)

April 18, 2017

Study Registration Dates

First Submitted

June 29, 2017

First Submitted That Met QC Criteria

July 20, 2017

First Posted (Actual)

July 24, 2017

Study Record Updates

Last Update Posted (Actual)

July 24, 2017

Last Update Submitted That Met QC Criteria

July 20, 2017

Last Verified

July 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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