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|NCT01186055 : Brain Activity and Smoking Cessation|
|Ages||Min: 18 Years Max: 65 Years|
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
3. Provide a baseline CO reading greater than 10 parts per million (ppm) at eligibility
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.
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
1. Antipsychotics (typical and atypical),
3. Anti-depressants (tricyclics, SSRI's, selective and nonselective MAOIs,
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,
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
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
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
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
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.
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
3. Inability to provide informed consent or complete any of the study tasks as
determined by the Principal Investigator and/or Study Physician.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01186055
| Link to official Clinicaltrials.gov listing