Alprazolam and Eating Behavior in Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Observational

Summary: 
      This study examines the role of anxiety in food intake among patients with AN by measuring
      caloric intake in a standardized, laboratory meal with alprazolam versus a placebo. Patients
      will participate in two test meal sessions, one after receiving alprazolam and one after
      receiving a placebo. Patients will be administered psychological measures of anxiety, mood,
      and eating behavior. Primary outcomes include caloric intake in a laboratory test meal and
      pre-meal anxiety levels.
    

Detailed description: 
      30 patients with Anorexia Nervosa (hospitalized at NYSPI 4-Center for acute weight
      restoration treatment) will be recruited to participate in this experiment. All subjects will
      be screened on admission and provide informed consent prior to participation. At the time of
      study procedures, participants will be medically stable and weigh ≥ 80% IBW. This minimum
      weight has been identified for patient safety given the test meal procedures. Subjects will
      participate in a total of two meal sessions on the BSU. Medical clearance will be determined
      by 4-Center clinical staff prior to the meal sessions. Study participation will not prolong
      nor interfere with the patient's treatment.

      The first test meal will occur after the patient has reached 80% IBW. The second test meal
      will occur within a week of the first. The procedures are identical for the two test
      sessions, and were based on those described by Sysko and colleagues (9). On the morning of
      the test meal, participants will be provided a standardized breakfast of ~300 kcal. They will
      not consume any additional food or liquid, other than water, prior to the test meal session
      approximately 4 hours later. Study medication will be administered at 10:00 am.

      Test meals will be conducted on the Biological Studies Unit (BSU) at NYSPI. Participants will
      be escorted to and from the BSU by research staff. Participants will complete questionnaires
      prior to receiving medication, prior to each test meal, and after the test meal is complete
      (see Table). Participants will be presented with an 83 fluid ounce covered opaque container
      with a straw on a table. Inside the container will be approximately 1500 grams (approximately
      1560 kcal) of strawberry yogurt shake. Patients will be informed that the meal consists of a
      strawberry yogurt shake, but will not be informed as to the amount provided in the container.
      Instructions before each test meal will inform patients that they should eat as much of the
      shake as they would like, and that the meal would serve as their lunch for the day. The
      participant will be alone in the room. For compliance and safety, patients will be observed
      through a closed circuit video monitor during the meal. The patient will be instructed to
      signal completion of the meal by ringing a bell. During the course of the meal, patients will
      be asked to rate anxiety periodically. After the test meal is complete, a staff member will
      debrief the participant and address any questions or concerns.

      Medication Administration: Participants will receive active medication (alprazolam 0.75 mg)
      on one test day and placebo on the other, in random order. Dose was selected based on the
      findings of Evans et al (8), who demonstrated statistically significant increases in caloric
      intake with doses of alprazolam 0.5 mg and 0.75 mg. Medication will be administered 2 hours
      prior to the test meal, as this is the timing of estimated peak plasma concentration (8).
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with Anorexia Nervosa hospitalized at NYSPI 4-C unit