Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01186055 : Brain Activity and Smoking Cessation
PhaseN/A
AgesMin: 18 Years Max: 65 Years
Eligibility
Inclusion Criteria:

1. Treatment-seeking smokers between the ages of 18 and 65, reporting consumption of at
least 10 cigarettes per day for at least the past 6 months.

2. Capable of giving written informed consent, which includes compliance with the
requirements and restrictions listed in the combined consent and HIPAA form, and are
fluent, English-speaking.

3. Provide a baseline CO reading greater than 10 parts per million (ppm) at eligibility
screening.

4. Women of childbearing potential must consent to use a medically accepted method of
birth control (e.g., condoms and spermicide, oral contraceptive, Depo-Provera
injection, contraceptive patch, tubal ligation or abstinence from sex) for the
duration of the study.

Exclusion Criteria:

Smoking Behavior

1. Use of chewing tobacco, snuff, or snus.

2. Current enrollment or plans to enroll in another research or smoking cessation
program in at least the next 7 months.

3. Anticipated use (within next 7 months) of other nicotine substitutes or smoking
cessation treatments/ medications.

4. Provide a baseline CO reading less than or equal to 10ppm.

Alcohol/Drug Exclusion Criteria:

1. Lifetime history of substance abuse and/or currently receiving treatment for
substance abuse (e.g., alcohol, opioids, cocaine, marijuana or stimulants).

2. Current alcohol consumption that exceeds greater than 25 standard drinks/week for men
and greater than 20 standard drinks/week for women over the last 6 months.

3. Breath alcohol reading (BrAC) greater than or equal to 0.01 at the Eligibility
Screening or any fMRI scanning session.

4. A positive urine drug screen (cocaine, opiates, benzodiazepines, tri-cyclic
antidepressants, amphetamines, methamphetamines, barbiturates, methadone, and
phencyclidine) at the Eligibility Screening or any fMRI scanning session.

Medication Exclusion Criteria:

Current use or recent discontinuation (within last 2-weeks) of the following psychotropic
medications:

1. Antipsychotics (typical and atypical),

2. Mood-stabilizers,

3. Anti-depressants (tricyclics, SSRI's, selective and nonselective MAOIs,
Wellbutrin/Zyban),

4. Anti-panic agents,

5. Anti-obsessive agents,

6. Anti-anxiety agents,

7. Prescription (e.g., Provigil, Ritalin) or over-the-counter stimulants,

8. Diet Pills/Anorectics,

9. Systemic Steroids,

10. Varenicline,

11. Daily use of prescription medications for chronic pain.

Medical Exclusion Criteria:

1. Women who are pregnant, breast-feeding or planning a pregnancy for the duration of
the study.

2. History or current diagnosis of psychosis, bipolar disorder, schizophrenia, or any
Axis 1 disorder as identified by the MINI (Mini International Neuropsychiatric
Interview) or self reported; for major depression, only a current diagnosis will be
considered ineligible.

3. History or current diagnosis of Attention-Deficit Hyperactivity Disorder (ADHD).

4. History of epilepsy or a seizure disorder.

5. Low or borderline intellectual functioning - determined by receiving a score of less
than 90 on the Shipley Institute of Living Scale (SILS) which correlates with the
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Estimated IQ Test (administered at
the eligibility screening visit).

fMRI-Related Exclusion Criteria:

1. Participation in study #810493 or #809858 within the last 6 months.

2. History of claustrophobia.

3. Being left-handed.

4. Color blindness.

5. Lifetime history of stroke.

6. Any impairment preventing participants from using the response pad necessary for the
cognitive testing.

7. Having a cochlear implant or wearing bilateral hearing aids.

8. Self-reported history of head trauma, brain or spinal tumor.

9. Self-reported use of pacemakers, certain metallic implants, or presence of metal in
the eye.

10. Circumstances or conditions that may interfere with magnetic resonance imaging (MRI).

11. Self-reported history of gunshot wounds.

12. Weight greater than 250lbs at any session.

General Exclusion:

1. Participation (within the last 6 months) in other studies at our center involving
cognitive testing (N-back, CPT or Go-No-Go Task).

2. Any medical condition or medication that could compromise participant safety or
interfere with imaging, as determined by the Principal Investigator and/or Study
Physician.

3. Inability to provide informed consent or complete any of the study tasks as
determined by the Principal Investigator and/or Study Physician.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01186055      |      Link to official Clinicaltrials.gov listing
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