The Neural Basis of Cue-Elicited Cigarette Craving and Its Control
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      Background:

      - One kind of drug craving, known as cue-elicited craving, occurs when a drug user who sees a
      drug-related cue (such as an image of someone using the drug) begins to feel a craving for
      the drug. Researchers are interested in studying how cue-elicited craving affects brain
      activity using functional magnetic resonance imaging (fMRI) and electroencephalography (EEG)
      data.

      Objectives:

      - To determine which parts of the brain are associated with or involved in controlling
      cue-related craving in smokers.

      Eligibility:

      - Individuals between 18 and 50 years of age who are current smokers (10 or more cigarettes
      per day) and agree to try to abstain from smoking for 1 week during the experiment.

      Design:

        -  Participants will visit a clinical center for up to four scanning sessions, and will be
           asked to perform two or three outpatient tasks at home over the course of the study.

        -  Scan 1: Training session with a mock fMRI scanner, followed by an actual fMRI scanning
           session and EEG in which participants respond to pictures.

        -  Outpatient Task 1: Tolerance test with nicotine patch (worn for 8 hours, followed by 12
           additional hours without cigarette use).

        -  Scans 2 and 3: Training session and fMRI scan and testing with either nicotine patch or
           placebo. Tasks in fMRI involve looking at cues, reporting craving and suppressing
           craving.

        -  Outpatient Task 2: Participants will keep an electronic diary for 10 to 14 days,
           responding to questions as directed by the researchers.

        -  Scans 4 and 5: Training session, fMRI scan and EEG, and testing in which participants
           will be instructed on methods to attempt to control cravings.

        -  Outpatient Task 3: Participants will keep an electronic diary for 14 days. For the first
           7 days, participants will be asked to attempt to abstain from nicotine; participants may
           smoke normally on the second 7 days.

        -  Participants will be contacted 1, 3, 6, and 12 months after the end of the study for
           follow-up questions on current smoking habits.
    

Detailed description: 
      Objective: Drug craving is a motivational state associated with a conscious desire to consume
      a drug (Fredrickson et al., 1995; Drummond, 2001). When drug abusers see drug-related cues,
      cue-elicited drug craving is induced (Drummond, 2001). The main goal of this investigation is
      to ascertain the neural basis of cue-elicited drug (e.g. cigarette) craving and its control
      in smokers.

      Study population: The experimental population for this investigation is nicotine-dependent
      adults aged 18-50 years old.

      Design: Participants will see the smoking-related cue or neutral cue and complete cognitive
      tasks (e.g. to report or regulate their craving, etc). At same time, we will employ
      functional magnetic resonance imaging (fMRI), real-time functional magnetic resonance imaging
      (rtfMRI), and electroencephalography (EEG) to measure brain activity.

      Outcome measures: There is no direct benefit to the participant by joining this study. Data
      from this study are expected to contribute to a better understanding of the neural processes
      of cigarette craving. Thus, the results may benefit the health of society. MRI-related risks
      (e.g., injury from metal implants, claustrophobia, and temporary hearing threshold
      alterations due to the loud banging noises) and nicotine-patch-related risks (e.g.,
      dizziness, headache, upset stomach, vomiting, diarrhea, redness or swelling at the patch
      site) to participants are minimized by careful prescreening and standard protection.
    

Intervention name(s): Real Time Feedback Training
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Primary purpose: Other
Keywords: Nicotine; Craving; fMRI; EEG; Real Time fMRI Feedback