Real Time fMRI and Quitting Smoking
Nicotine Use Disorder
About this trial
This is an interventional treatment trial for Nicotine Use Disorder focused on measuring nicotine treatment, real time fMRI
Eligibility Criteria
Inclusion Criteria:
- 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;
- Planning to live in the area for at least the next month;
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form;
- Able to communicate fluently in English (speaking, writing, and reading).
Exclusion Criteria:
Smoking Behavior:
- Use of chewing tobacco or snuff or cigars;
- Current enrollment or plans to enroll in another smoking cessation program or research study in the next month;
- Current or anticipated (within the next month) use of smoking cessation medications or nicotine replacement therapy (NRT);
- A baseline carbon monoxide (CO) reading less than 10ppm.
Alcohol/Drugs:
- Current alcohol consumption that exceeds 25 standard drinks/week;
- 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:
- Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix, NRT);
- Anti-psychotic medications;
Any medication that could compromise participant safety as determined by the Principal Investigator and/or Study Physician;
Daily use of:
- Opiate-containing medications for chronic pain.
Medical/Neuropsychiatric:
- 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.
- History of epilepsy or a seizure disorder;
- History of stroke;
- Self-reported brain (or CNS) or spinal tumor;
- Self-reported history of head trauma;
- Self-reported history or current diagnosis of psychosis.
fMRI-Related:
- Self-reported use of pacemakers, certain metallic implants, or presence of metal in the eye as contraindicated for fMRI;
- Self-reported history of claustrophobia;
- Being left-handed;
- Color blindness;
- Weight greater than 250lbs at intake;
- Self-reported history of gunshot wounds;
- Any impairment preventing participants from using the response pad necessary for the computer tasks;
- Circumstances or conditions that may interfere with magnetic resonance imaging (MRI).
General Exclusion:
- Any medical condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator;
- Enrollment or plans to enroll in another research study;
- Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator.
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Real-time neurofeedback training group
No-feedback control group
We propose to use rt-fMRI neurofeedback training to help smokers consciously modulate activation in areas related to cravings and self-control in order to improve control smoking urges. In this arm, participants will complete four sessions: an intake session and 3 neurofeedback scanning visits. The primary outcome is the ability to resist smoking during a validated smoking lapse paradigm. Secondary outcomes include changes in brain activity in areas related to craving and self-control, and self-reported craving for cigarettes.
We propose to use rt-fMRI neurofeedback training to help smokers consciously modulate activation in areas related to cravings and self-control in order to improve control smoking urges. In the control group arm, participants will complete four sessions: an intake session and 3 scanning visits with no neurofeeback. The primary outcome is the ability to resist smoking during a validated smoking lapse paradigm. Secondary outcomes include changes in brain activity in areas related to craving and self-control, and self-reported craving for cigarettes.