Effects of Varenicline on Brain Activity During Nicotine Abstinence

This is an interventional treatment trial for Nicotine Dependence focused on measuring Varenicline, Imaging, fMRI Read More

Inclusion Criteria:

1. Treatment-seeking smokers between the ages of 18 and 65, that smoke at least 10 cigarettes/day for at least the past 6 months
2. Provide a baseline CO (carbon monoxide) reading of >10ppm
3. Provide written informed consent and are fluent, English-speaking
4. Weight of equal to or less than 300 lbs

Exclusion Criteria:

Smoking Behavior

1. Use of chewing tobacco, snuff or cigars
2. Current enrollment or plans to enroll in another smoking cessation program in the next 5 months
3. Plan to use other nicotine substitutes or smoking cessation treatments in the next 5 months
4. Provide a baseline CO (carbon monoxide) reading ≤10 ppm

Alcohol/Drug Exclusion Criteria

1. History of substance abuse and/or currently receiving treatment for substance abuse
2. Current alcohol consumption that exceeds 25 standard drinks/week
3. A breath alcohol concentration reading ≥ 0.01 at the H&P (health & physical) screening or either of the lab sessions

Medication Exclusion Criteria

1. Prior use of Chantix

2. Current use or recent discontinuation (within last 14-days) of the following medications:

   1. Any form of smoking cessation medication

   2. Any form of anti-psychotic medications that includes:

      • antipsychotics,
      • atypical antipsychotics,
      • mood-stabilizers,
      • anti-depressants (tricyclic, SSRI, MAOI),
      • anti-panic agents,
      • anti-obsessive agents,
      • anti-anxiety agents, and
      • stimulants (e.g., Provigil, Ritalin)
      • herbal medications (St. John's Wort)
   3. Opioid medication for chronic pain
   4. Anti-coagulants
   5. Any heart medications
   6. Daily medication for asthma

Medical Exclusion Criteria

1. Women who are pregnant, planning a pregnancy, or lactating;
2. History or current diagnosis of psychosis, current major depression, bipolar disorder, ADHD, schizophrenia, or any Axis 1 disorder as identified by the MINI
3. Serious or unstable disease within the past 6 months (heart disease, HIV)
4. Diagnosis of cancer in the past 6 months or if successful treatment for cancer has not ended within the past 6 months
5. History of epilepsy or a seizure disorder
6. History or current diagnosis (last 6-months) of abnormal rhythms and/or tachycardia (>100 beats/minute); history or current diagnosis of COPD (chronic obstructive pulmonary disease), cardiovascular disease (stroke, angina, coronary heart disease), heart attack in the last 6 months, uncontrolled hypertension (SBP>150 or DBP>90)
7. History of kidney and/or liver failure (including transplant)
8. History of head trauma or prior seizure; family history of a seizure disorder, brain (or central nervous system) tumor
9. Use of pacemakers, certain metallic implants, or presence of metal in the eye as contraindicated for MRI (magnetic resonance imaging);
10. Low or borderline intellectual functioning - determined by receiving a score <80 on the Shipley verbal IQ Test
11. Non-English speaking; determined at phone screen
12. History of claustrophobia (contraindicated for MRI) or color blindness (task requires color recognition); self-report at telephone screen
13. Being left-handed
14. Any fore-limb deformity
15. Wearing cochlear implant or bi-lateral hearing aids

General Exclusion

1. Any medical condition 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.
3. Any physical or visual impairment that may prevent the individual from using a computer keyboard or completing any study tasks.