Assessment of High Dose Transdermal Nicotine for Fast Metabolizers of Nicotine
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Nicoderm CQ transdermal nicotine; placebo
Intervention description: Transdermal nicotine patch (21mg vs. 42mg), 8 weeks; placebo patch
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: nicotine dependence; nicotine replacement therapy; transdermal nicotine; nicotine metabolism; high dose

Summary:

      Unfortunately, the investigators still need to assess and identify novel ways to help people
      quit smoking. Differences between people in terms of how fast they metabolize nicotine
      influences response to transdermal nicotine patches, the most popular nicotine dependence
      treatment, and it affects plasma levels of nicotine from treatment. These studies suggest
      that fast metabolizers of nicotine may show better quit rates if they receive higher doses of
      transdermal nicotine. This preliminary study is designed to assess, for the first time,
      whether fast nicotine metabolizers show higher quit rates if given high dose transdermal
      nicotine, versus standard dose. The study findings may help to support a subsequent large
      trial to assess standard versus high dose transdermal nicotine for slow versus fast
      metabolizers of nicotine, which may lead to a more personalized approach to treating nicotine
      dependence using the nicotine patch to improve therapeutic benefits of transdermal nicotine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females age 18-45 who smoke > 10 cigarettes/ day;

          2. Able to communicate in English;

          3. Able to use NRT safely (e.g., no allergy to latex);

          4. Able to provide written informed consent for study procedures;

          5. Residing in the geographic area for at least 6 months; and

          6. A 3-HC/cotinine ratio in the top quartile of the distribution (Schnoll et al., 2008).
             Age 45 was selected as an upper limit to reduce the likelihood of adverse effects from
             high dose transdermal nicotine.

        Exclusion Criteria:

          1. History of substance abuse or currently receiving treatment for substance abuse (e.g.,
             alcohol, opioids, cocaine, marijuana);

          2. Current (last 6-months) alcohol consumption that exceeds 25 standard drinks/week.

          3. Current use or discontinuation within last 14 days of:

               -  Smoking cessation medications (bupropion, Chantix, NRT);

               -  Antipsychotics, atypicals, mood-stabilizers, anti-depressants (tricyclics, SSRIs,
                  MAOIs), anti-panic agents, anti-obsessive agents, anti-anxiety agents,
                  stimulants);

               -  Medication for pain;

               -  Anti-coagulants;

               -  Heart medications;

               -  Daily medication for asthma or diabetes.

          4. Women who are pregnant, planning a pregnancy, or lactating;

          5. History or current diagnosis of psychosis, major depression or bipolar disorder,
             psychotic disorder, or generalized anxiety disorder;

          6. Serious/unstable disease within the past 6 months (e.g., cancer [but melanoma],
             HIV/AIDS);

          7. History of epilepsy or seizure disorder;

          8. History or diagnosis within the last 6 months of abnormal rhythms and/or tachycardia
             (>100 beats/minute); history or current diagnosis of COPD, cardiovascular disease
             (stroke, angina), heart attack in the last 6 months, uncontrolled hypertension
             (SBP>150 or DBP>90);

          9. History of kidney or liver failure.

         10. Any medical condition or medication that could compromise safety as determined by a
             study physician;

         11. Inability to provide informed consent or complete the study tasks as determined by the
             Principal Investigator or study physician.