Real Time fMRI and Quitting Smoking
- Conditions
- Nicotine Use Disorder
- Interventions
- Behavioral: Realtime biofeedback using fMRI
- Registration Number
- NCT03302026
- Lead Sponsor
- University of Pennsylvania
- 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. 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.
- 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. Nicotine replacement therapy, the most widely used pharmacotherapy, yields end of treatment quit rates of \<25% suggesting that managing nicotine withdrawal is not sufficient. A smoker's response to smoking cues is one factor that increases risk of relapse. 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. First, we will conduct a pilot study in 12 smokers for technical development and to evaluate the feasibility of the proposed study procedures. 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. Upon successful completion of the technical development phase, we will proceed to a proof-of-concept phase, which will recruit 72 smokers to evaluate the efficacy of NFT for smoking behavior.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- 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).
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Real-time neurofeedback training group Realtime biofeedback using fMRI 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.
- Primary Outcome Measures
Name Time Method Smoking Lapse Paradigm Study session 3 (scan day 3) Time (sec) to first cigarette during a 50 minute monitored smoking lapse period in smoking laboratory
- Secondary Outcome Measures
Name Time Method Cue induced brain signal change Study session 3 (scan day 3) Change in mean percent signal change for Cue minus Neutral contrasts in activated brain regions
Trial Locations
- Locations (1)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States