Pharmacogenetics of Nicotine Addiction Treatment

Exclusion Criteria

• •Smoking Behavior
• •1. Regular (daily) use of chewing tobacco, snuff or snus.
• •2. Current enrollment or plans to enroll in another smoking cessation or research program in the next 12 months.
• •3. Plan to use other nicotine substitutes or smoking cessation treatments in the next 12 months.
• •4. Provide a baseline CO reading less than or equal to 10ppm at the Intake Session.
• •1. History (within the last year) or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants), excluding nicotine.
• •2. Current use of cocaine and/or methamphetamines (urine drug screen at the Intake Session).
• •3. Current alcohol consumption that exceeds greater than 25 standard drinks/week.
• •4. Current alcohol abuse or dependence.
• •5. Current non-alcoholic psychoactive substance abuse or dependence.
• •1. Women who are pregnant, planning a pregnancy, or lactating.
• •2. History of epilepsy or a seizure disorder.
• •3. Current medical problems for which transdermal nicotine is contraindicated including:
• •* Allergy to latex.
• •* History of kidney and/or liver disease, including transplant (self-report).
• •* Uncontrolled hypertension (determined as a Systolic Blood pressure (SBP) reading greater than 160 and/or a Diastolic Blood Pressure (DBP) greater than 100).
• •4. Serious or unstable disease within the past 6 months.
• •5. History (last 6 months) of abnormal heart rhythms, tachycardia and cardiovascular disease (stroke, angina, heart attack) may result in ineligibility. These conditions will be evaluated on a case by case basis by the Study Physician.
• •6. Inability to provide a blood sample to be used to assess nicotine metabolite ratio.
• •1. Current diagnosis of major depression. Persons with a history of major depression, if stable for 6 months or longer, are eligible, provided they are not excluded based on medications (below).
• •2. Any suicide risk score on MINI or self-reported suicide attempt on telephone screen.
• •3. Current or past hypomanic/manic episode.
• •4. History or current diagnosis of Post Traumatic Stress Disorder (PTSD).
• •5. History or current diagnosis of psychotic disorder, bipolar disorder, schizophrenia.
• •1. Current use or recent discontinuation (within the last 14-days) of:
• •* Smoking cessation medication (e.g. Zyban, Wellbutrin, Wellbutrin SR, Chantix); NOTE: Once participants are found eligible for the study, they are instructed to use the smoking cessation medication provided to them by the study staff. If a subject reports an isolated (non-daily) instance of using a non-study smoking cessation medication, the study physician and PI will evaluate the situation and determine if it is safe for the subject to continue participation.
• •* Anti-psychotic medications.
• •* Certain medications used to treat depression, including Wellbutrin, Monoamine Oxidase Inhibitors (MAOIs), and tricyclic antidepressants.
• •* Prescription stimulants (e.g. Provigil, Ritalin, Adderall).
• •2. Current use of:
• •* Nicotine replacement therapy (NRT); NOTE: Once participants are found eligible for the study, they are told they should only use the NRT provided to them by the study staff. If a subject reports an isolated (non-daily) instance of NRT use during the study, they may be permitted to continue.
• •* Tagamet (cimetidine).
• •* Heart medications such as digoxin, quinidine, nitroglycerin; use of these medications may result in ineligibility and will therefore be evaluated on a case-by-case basis by the Study Physician.
• •* Anti-coagulants (e.g., Coumadin, Warfarin).
• •3. Daily use of:
• •* Opiate-containing medications for chronic pain; if a participant reports taking an opiate-containing medication every day for the 14 days prior to the telephone screen and/or Intake Session, the participant will be ineligible.
• •* Rescue Inhalers (e.g. albuterol, proventil, ventolin, or maxair)
• •General Exclusion
• •1. Any medical condition, illness, disorder or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
• •2. Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.