Effects of Varenicline on Brain Activity During Nicotine Abstinence

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This project aims to define mechanisms through which varenicline might be an effective smoking cessation medication.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pennsylvania
• Collaborators: National Cancer Institute (NCI); Pfizer
• Treatments: Varenicline

Criteria

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.