Clinical Trial Details
Braintumor Website

[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.]

NCT03302026 : Real Time fMRI and Quitting Smoking
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. Planning to live in the area for at least the next month;

3. Capable of giving written informed consent, which includes compliance with the
requirements and restrictions listed in the combined consent and HIPAA form;

4. Able to communicate fluently in English (speaking, writing, and reading).

Exclusion Criteria:

Smoking Behavior:

1. Use of chewing tobacco or snuff or cigars;

2. Current enrollment or plans to enroll in another smoking cessation program or research
study in the next month;

3. Current or anticipated (within the next month) use of smoking cessation medications or
nicotine replacement therapy (NRT);

4. A baseline carbon monoxide (CO) reading less than 10ppm.

Alcohol/Drugs:

1. Current alcohol consumption that exceeds 25 standard drinks/week;

2. Positive breath alcohol concentration test (BrAC greater than or equal to 0.01) at
intake; a. Participants testing positive for breath alcohol with a reading equal to or
greater than .08 (the legal driving limit) or who are visibly impaired will be
instructed not to drive themselves home after the appointment. If a participant needs
to use a phone to call for a safe ride home, an office telephone will be made
available to the participant.

Medication:

Current use or recent discontinuation (within the past 30 days at the time of Intake) of:

1. Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix, NRT);

2. Anti-psychotic medications;

3. Any medication that could compromise participant safety as determined by the Principal
Investigator and/or Study Physician;

Daily use of:

4. Opiate-containing medications for chronic pain.

Medical/Neuropsychiatric:

1. Women who are pregnant, planning a pregnancy, and/or breast feeding. All female
subjects of childbearing potential will undergo a urine pregnancy test at Intake and
at each scan session.

2. History of epilepsy or a seizure disorder;

3. History of stroke;

4. Self-reported brain (or CNS) or spinal tumor;

5. Self-reported history of head trauma;

6. Self-reported history or current diagnosis of psychosis.

fMRI-Related:

1. Self-reported use of pacemakers, certain metallic implants, or presence of metal in
the eye as contraindicated for fMRI;

2. Self-reported history of claustrophobia;

3. Being left-handed;

4. Color blindness;

5. Weight greater than 250lbs at intake;

6. Self-reported history of gunshot wounds;

7. Any impairment preventing participants from using the response pad necessary for the
computer tasks;

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

General Exclusion:

1. Any medical condition, illness, disorder, or concomitant medication that could
compromise participant safety or treatment, as determined by the Principal
Investigator;

2. Enrollment or plans to enroll in another research study;

3. Inability to provide informed consent or complete any of the study tasks as determined
by the Principal Investigator.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03302026      |      Link to official Clinicaltrials.gov listing
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