Real Time fMRI and Quitting Smoking
Condition: Nicotine Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional

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.
    

Intervention name(s): Realtime biofeedback using fMRI
Intervention type(s): Behavioral
Intervention description(s): Real-time fMRI (rt-fMRI) allows for rapid analysis of brain activation while an individual is actively performing a task, and can be used to provide real-time neurofeedback to individuals during fMRI scanning. Using neurofeedback, individuals can learn to modulate activity in specific regions of the brain. 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. Participants will complete four sessions: an intake session and 3 scanning visits. The primary outcome is the ability to resist smoking during a validated smoking lapse paradigm.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The proposed study will evaluate the effects of rt-fMRI neurofeedback training on the ability to resist craving for cigarettes. The study will be conducted in two phases: a technical development phase and a proof-of-concept phase focused on efficacy. The technical development phase will be completed before beginning the proof-of-concept phase. Eligible consenting treatment-seeking smokers complete an intake session and then be randomized to an active NFT group or a control group. Both groups will complete three scanning sessions, followed by a smoking resist evaluation.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: nicotine treatment; real time fMRI