<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03227679</url>
  </required_header>
  <id_info>
    <org_study_id>160512</org_study_id>
    <nct_id>NCT03227679</nct_id>
  </id_info>
  <brief_title>Metabolism-informed Care for Smoking Cessation</brief_title>
  <official_title>Metabolism-informed Care for Smoking Cessation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nicotine mediates smoking's addictive effects in the brain. The ratio of 3-hydroxycotinine to&#xD;
      cotinine, known as the nicotine metabolite ratio, or NMR, is a genetically- informed&#xD;
      biomarker reflecting hepatic CYP2A6 activity and the rate of nicotine metabolism. In light of&#xD;
      a recent randomized controlled trial (RCT) in humans in Lancet Respiratory Medicine, which&#xD;
      found that the NMR can be used to individualize treatment for smokers, our pilot study aims&#xD;
      to determine the feasibility of using NMR to guide selection of pharmacotherapy in clinical&#xD;
      populations of daily smokers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Consenting participants will be assigned to guideline-based care (GBC: incorporating national&#xD;
      guidelines and more recent evidence from clinical trials of pharmacotherapy for smoking&#xD;
      cessation) or metabolism-informed care (MIC: identical to GBC but selection of medication&#xD;
      based on NMR result). All participants received counseling from a nurse level certified&#xD;
      tobacco counseling. After consent, participants undergo a blood draw for NMR, complete a&#xD;
      baseline questionnaire, and are randomized to GBC or MIC. At approximately 1, 3, and 6 months&#xD;
      post-consent, participants will provide follow up information via telephone questionnaire&#xD;
      regarding symptoms, confidence in quitting, use of medications, and smoking status. At the&#xD;
      6-month follow-up time point, if a participant self-reports abstinence from smoking, the&#xD;
      participant will be asked to complete a survey in-person and provide a sample of end-expired&#xD;
      carbon monoxide for biochemical validation. At the 6 month time point, GBC participants who&#xD;
      continue to smoke will be offered an additional phone call from the nurse tobacco counselor&#xD;
      in which the results of the baseline NMR test will be given, along with a second prescription&#xD;
      for a smoking cessation medication based on the NMR results (i.e., single arm crossover&#xD;
      design). Two weeks after this additional phone call, the patient will be contacted for a&#xD;
      final survey regarding use of medication and smoking status.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 18, 2016</start_date>
  <completion_date type="Actual">April 18, 2017</completion_date>
  <primary_completion_date type="Actual">October 8, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Parallel arm pilot trial with a single-arm crossover design</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>Participant, Nurse, and RAs all blinded to random Arm assignment, none blinded to medication prescription</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Theoretical Endorsement of MIC as assessed by level of agreement to a set of seven 5-point Likert Scale questions</measure>
    <time_frame>Baseline</time_frame>
    <description>Likert Scale from Strongly Disagree to Strongly Agree on items assessing attitudes toward and perceptions of using metabolism information to guide medical care</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptance of MIC medication recommendation as assessed by concordance between MIC recommendation and actual prescribed medication</measure>
    <time_frame>At 4 weeks post-baseline</time_frame>
    <description>Level of agreement between participant's prescribed medication and the medication that would be recommended based on Nicotine Metabolite Ratio</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Confidence in Quitting</measure>
    <time_frame>Baseline - 6 months</time_frame>
    <description>Self-reported confidence in ability to quit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Use/Compliance</measure>
    <time_frame>1 - 6 months</time_frame>
    <description>Use of prescribed medication, as directed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking Status</measure>
    <time_frame>6 months</time_frame>
    <description>Self-reported and/or biochemically validated smoking cessation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Tobacco Use</condition>
  <condition>Tobacco Use Cessation</condition>
  <arm_group>
    <arm_group_label>Metabolism-Informed Care (MIC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Guideline-Based Care (GBC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nicotine Metabolite Ratio</intervention_name>
    <description>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.</description>
    <arm_group_label>Metabolism-Informed Care (MIC)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Varenicline</intervention_name>
    <description>FDA-approved smoking cessation pharmacotherapy</description>
    <arm_group_label>Guideline-Based Care (GBC)</arm_group_label>
    <arm_group_label>Metabolism-Informed Care (MIC)</arm_group_label>
    <other_name>Chantix</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupropion</intervention_name>
    <description>FDA-approved smoking cessation pharmacotherapy</description>
    <arm_group_label>Guideline-Based Care (GBC)</arm_group_label>
    <arm_group_label>Metabolism-Informed Care (MIC)</arm_group_label>
    <other_name>Zyban</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicotine patch</intervention_name>
    <description>FDA-approved smoking cessation pharmacotherapy</description>
    <arm_group_label>Guideline-Based Care (GBC)</arm_group_label>
    <arm_group_label>Metabolism-Informed Care (MIC)</arm_group_label>
    <other_name>Nicotine Replacement Therapy (NRT)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Smokes ≥ 5 cigarettes per day&#xD;
&#xD;
          -  Willing to give up all forms of tobacco (5/10/2016 - 6/27/2016)&#xD;
&#xD;
          -  Medically cleared (i.e., no contraindications in Section 3) to receive at least 2 FDA-&#xD;
             approved smoking cessation medications&#xD;
&#xD;
          -  Willing to use the medications for which medically cleared (individually, not in&#xD;
             combination; only applicable if Medically Cleared = Yes)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current diagnosis of schizophrenia, psychosis, active suicidal ideation, dementia, or&#xD;
             severe mental retardation&#xD;
&#xD;
          -  Receiving palliative or hospice care&#xD;
&#xD;
          -  Currently pregnant or breastfeeding&#xD;
&#xD;
          -  Hospitalized for a psychiatric condition in the past year (5/10/2016 - 6/27/2016)&#xD;
&#xD;
          -  Hospitalized for a psychiatric condition in the past 3 months or change in psychiatric&#xD;
             medications in last 3 months (6/28/2016 forward)&#xD;
&#xD;
          -  Telephone problems that would preclude participation (e.g., can't receive calls&#xD;
             reliably)&#xD;
&#xD;
          -  Not able to read and speak English&#xD;
&#xD;
          -  Abstinent from cigarettes for &gt;3 days (b/c NMR not reliable after 72 hours)&#xD;
&#xD;
          -  Used smoking cessation medications in the last 7 days (5/10/2016 - 6/27/2016)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Quinn Wells, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dawn Beaulieu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Matthew Freiberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hilary Tindle, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <reference>
    <citation>World Health Organization. Assessment of the Economic Costs of Smoking. Economics of tobacco toolkit. 2011;:1-116.</citation>
  </reference>
  <reference>
    <citation>Agaku IT, King BA, Dube SR; Centers for Disease Control and Prevention (CDC). Current cigarette smoking among adults - United States, 2005-2012. MMWR Morb Mortal Wkly Rep. 2014 Jan 17;63(2):29-34.</citation>
    <PMID>24430098</PMID>
  </reference>
  <reference>
    <citation>Benowitz NL. Pharmacology of nicotine: addiction, smoking-induced disease, and therapeutics. Annu Rev Pharmacol Toxicol. 2009;49:57-71. doi: 10.1146/annurev.pharmtox.48.113006.094742.</citation>
    <PMID>18834313</PMID>
  </reference>
  <reference>
    <citation>Hukkanen J, Jacob P 3rd, Benowitz NL. Metabolism and disposition kinetics of nicotine. Pharmacol Rev. 2005 Mar;57(1):79-115. doi: 10.1124/pr.57.1.3.</citation>
    <PMID>15734728</PMID>
  </reference>
  <reference>
    <citation>Chen LS, Bloom AJ, Baker TB, Smith SS, Piper ME, Martinez M, Saccone N, Hatsukami D, Goate A, Bierut L. Pharmacotherapy effects on smoking cessation vary with nicotine metabolism gene (CYP2A6). Addiction. 2014 Jan;109(1):128-137. doi: 10.1111/add.12353. Epub 2013 Nov 11.</citation>
    <PMID>24033696</PMID>
  </reference>
  <reference>
    <citation>Dempsey D, Tutka P, Jacob P 3rd, Allen F, Schoedel K, Tyndale RF, Benowitz NL. Nicotine metabolite ratio as an index of cytochrome P450 2A6 metabolic activity. Clin Pharmacol Ther. 2004 Jul;76(1):64-72. doi: 10.1016/j.clpt.2004.02.011.</citation>
    <PMID>15229465</PMID>
  </reference>
  <reference>
    <citation>Lerman C, Schnoll RA, Hawk LW Jr, Cinciripini P, George TP, Wileyto EP, Swan GE, Benowitz NL, Heitjan DF, Tyndale RF; PGRN-PNAT Research Group. Use of the nicotine metabolite ratio as a genetically informed biomarker of response to nicotine patch or varenicline for smoking cessation: a randomised, double-blind placebo-controlled trial. Lancet Respir Med. 2015 Feb;3(2):131-138. doi: 10.1016/S2213-2600(14)70294-2. Epub 2015 Jan 12.</citation>
    <PMID>25588294</PMID>
  </reference>
  <reference>
    <citation>Hughes JR, Stead LF, Hartmann-Boyce J, Cahill K, Lancaster T. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2014 Jan 8;2014(1):CD000031. doi: 10.1002/14651858.CD000031.pub4.</citation>
    <PMID>24402784</PMID>
  </reference>
  <reference>
    <citation>Bauld L, Bell K, McCullough L, Richardson L, Greaves L. The effectiveness of NHS smoking cessation services: a systematic review. J Public Health (Oxf). 2010 Mar;32(1):71-82. doi: 10.1093/pubmed/fdp074. Epub 2009 Jul 28.</citation>
    <PMID>19638397</PMID>
  </reference>
  <reference>
    <citation>2008 PHS Guideline Update Panel, Liaisons, and Staff. Treating tobacco use and dependence: 2008 update U.S. Public Health Service Clinical Practice Guideline executive summary. Respir Care. 2008 Sep;53(9):1217-22. No abstract available.</citation>
    <PMID>18807274</PMID>
  </reference>
  <reference>
    <citation>Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med. 1998 Sep 14;158(16):1789-95. doi: 10.1001/archinte.158.16.1789.</citation>
    <PMID>9738608</PMID>
  </reference>
  <reference>
    <citation>Anthenelli RM, Benowitz NL, West R, St Aubin L, McRae T, Lawrence D, Ascher J, Russ C, Krishen A, Evins AE. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet. 2016 Jun 18;387(10037):2507-20. doi: 10.1016/S0140-6736(16)30272-0. Epub 2016 Apr 22.</citation>
    <PMID>27116918</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>June 29, 2017</study_first_submitted>
  <study_first_submitted_qc>July 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 20, 2017</last_update_submitted>
  <last_update_submitted_qc>July 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Hilary Tindle</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Personalized Medicine</keyword>
  <keyword>Nicotine Metabolite Ratio (NMR)</keyword>
  <keyword>Varenicline</keyword>
  <keyword>Nicotine Replacement Therapy (NRT)</keyword>
  <keyword>Smoking Cessation</keyword>
  <keyword>Pharmacotherapy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupropion</mesh_term>
    <mesh_term>Nicotine</mesh_term>
    <mesh_term>Varenicline</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 6, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03227679/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 15, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03227679/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03227679
org study id: 160512
nct id: NCT03227679
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Parallel arm pilot trial with a single-arm crossover design
primary purpose: Health Services Research
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: Participant, Nurse, and RAs all blinded to random Arm assignment, none blinded to medication prescription
measure: Theoretical Endorsement of MIC as assessed by level of agreement to a set of seven 5-point Likert Scale questions
time frame: Baseline
description: Likert Scale from Strongly Disagree to Strongly Agree on items assessing attitudes toward and perceptions of using metabolism information to guide medical care
measure: Acceptance of MIC medication recommendation as assessed by concordance between MIC recommendation and actual prescribed medication
time frame: At 4 weeks post-baseline
description: Level of agreement between participant's prescribed medication and the medication that would be recommended based on Nicotine Metabolite Ratio
measure: Confidence in Quitting
time frame: Baseline - 6 months
description: Self-reported confidence in ability to quit
measure: Medication Use/Compliance
time frame: 1 - 6 months
description: Use of prescribed medication, as directed
measure: Smoking Status
time frame: 6 months
description: Self-reported and/or biochemically validated smoking cessation
arm group label: Metabolism-Informed Care (MIC)
arm group type: Active Comparator
description: 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.
arm group label: Guideline-Based Care (GBC)
arm group type: Active Comparator
description: 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.
intervention type: Other
intervention name: Nicotine Metabolite Ratio
description: 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.
arm group label: Metabolism-Informed Care (MIC)
intervention type: Drug
intervention name: Varenicline
description: FDA-approved smoking cessation pharmacotherapy
arm group label: Guideline-Based Care (GBC)
arm group label: Metabolism-Informed Care (MIC)
other name: Chantix
intervention type: Drug
intervention name: Bupropion
description: FDA-approved smoking cessation pharmacotherapy
arm group label: Guideline-Based Care (GBC)
arm group label: Metabolism-Informed Care (MIC)
other name: Zyban
intervention type: Drug
intervention name: Nicotine patch
description: FDA-approved smoking cessation pharmacotherapy
arm group label: Guideline-Based Care (GBC)
arm group label: Metabolism-Informed Care (MIC)
other name: Nicotine Replacement Therapy (NRT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Quinn Wells, MD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
last name: Dawn Beaulieu, MD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
last name: Matthew Freiberg, MD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
last name: Hilary Tindle, MD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
citation: World Health Organization. Assessment of the Economic Costs of Smoking. Economics of tobacco toolkit. 2011;:1-116.
citation: Agaku IT, King BA, Dube SR; Centers for Disease Control and Prevention (CDC). Current cigarette smoking among adults - United States, 2005-2012. MMWR Morb Mortal Wkly Rep. 2014 Jan 17;63(2):29-34.
PMID: 24430098
citation: Benowitz NL. Pharmacology of nicotine: addiction, smoking-induced disease, and therapeutics. Annu Rev Pharmacol Toxicol. 2009;49:57-71. doi: 10.1146/annurev.pharmtox.48.113006.094742.
PMID: 18834313
citation: Hukkanen J, Jacob P 3rd, Benowitz NL. Metabolism and disposition kinetics of nicotine. Pharmacol Rev. 2005 Mar;57(1):79-115. doi: 10.1124/pr.57.1.3.
PMID: 15734728
citation: Chen LS, Bloom AJ, Baker TB, Smith SS, Piper ME, Martinez M, Saccone N, Hatsukami D, Goate A, Bierut L. Pharmacotherapy effects on smoking cessation vary with nicotine metabolism gene (CYP2A6). Addiction. 2014 Jan;109(1):128-137. doi: 10.1111/add.12353. Epub 2013 Nov 11.
PMID: 24033696
citation: Dempsey D, Tutka P, Jacob P 3rd, Allen F, Schoedel K, Tyndale RF, Benowitz NL. Nicotine metabolite ratio as an index of cytochrome P450 2A6 metabolic activity. Clin Pharmacol Ther. 2004 Jul;76(1):64-72. doi: 10.1016/j.clpt.2004.02.011.
PMID: 15229465
citation: Lerman C, Schnoll RA, Hawk LW Jr, Cinciripini P, George TP, Wileyto EP, Swan GE, Benowitz NL, Heitjan DF, Tyndale RF; PGRN-PNAT Research Group. Use of the nicotine metabolite ratio as a genetically informed biomarker of response to nicotine patch or varenicline for smoking cessation: a randomised, double-blind placebo-controlled trial. Lancet Respir Med. 2015 Feb;3(2):131-138. doi: 10.1016/S2213-2600(14)70294-2. Epub 2015 Jan 12.
PMID: 25588294
citation: Hughes JR, Stead LF, Hartmann-Boyce J, Cahill K, Lancaster T. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2014 Jan 8;2014(1):CD000031. doi: 10.1002/14651858.CD000031.pub4.
PMID: 24402784
citation: Bauld L, Bell K, McCullough L, Richardson L, Greaves L. The effectiveness of NHS smoking cessation services: a systematic review. J Public Health (Oxf). 2010 Mar;32(1):71-82. doi: 10.1093/pubmed/fdp074. Epub 2009 Jul 28.
PMID: 19638397
citation: 2008 PHS Guideline Update Panel, Liaisons, and Staff. Treating tobacco use and dependence: 2008 update U.S. Public Health Service Clinical Practice Guideline executive summary. Respir Care. 2008 Sep;53(9):1217-22. No abstract available.
PMID: 18807274
citation: Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med. 1998 Sep 14;158(16):1789-95. doi: 10.1001/archinte.158.16.1789.
PMID: 9738608
citation: Anthenelli RM, Benowitz NL, West R, St Aubin L, McRae T, Lawrence D, Ascher J, Russ C, Krishen A, Evins AE. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet. 2016 Jun 18;387(10037):2507-20. doi: 10.1016/S0140-6736(16)30272-0. Epub 2016 Apr 22.
PMID: 27116918
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Hilary Tindle
investigator title: Associate Professor of Medicine
mesh term: Bupropion
mesh term: Nicotine
mesh term: Varenicline
sharing ipd: No
provided document: 
provided document: 