A Proof-of-concept Study of Real-time fMRI Neurofeedback Training for Smoking Cessation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Nicotine Use Disorder
- Sponsor
- University of Pennsylvania
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Smoking Lapse Paradigm
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
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:
Outcomes
Primary Outcomes
Smoking Lapse Paradigm
Time Frame: Study session 3 (scan day 3)
Time (sec) to first cigarette during a 50 minute monitored smoking lapse period in smoking laboratory
Secondary Outcomes
- Cue induced brain signal change(Study session 3 (scan day 3))