Status:
COMPLETED
Real Time fMRI and Quitting Smoking
Lead Sponsor:
University of Pennsylvania
Conditions:
Nicotine Use Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study will examine how real-time functional magnetic resonance imaging (rt-fMRI) feedback can be used to modulate brain activation in the context of smoking cues in order to resist craving. Parti...
Detailed Description
Smoking is the greatest preventable cause of mortality and a significant economic burden. Even with the best available treatments, most smokers relapse within days or weeks after a quit attempt. Nicot...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2019
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03302026
Start Date
January 2 2018
End Date
March 28 2019
Last Update
April 16 2019
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104