Real Time fMRI and Quitting Smoking
Completed · Not applicable
Conditions studied: Nicotine Use Disorder
In brief
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. Participants will complete a total of three fMRI scanning sessions with a cue suppression task with or without neurofeedback training (NFT). Participants will be randomized to an active group (active NFT) or a control group (no NFT) during the scanning sessions. At the end of the third session, all participants will complete a validated smoking lapse laboratory paradigm to evaluate effects of NFT on smoking behavior.
Key facts
- Study ID
- NCT03302026
- Run by
- University of Pennsylvania
- People needed
- 46
- Starts
- 2018-01-02
- Expected to finish
- 2019-03-28
- Last updated by the study team
- 2019-04-16
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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;
Where it is running
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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