Alprazolam and Eating Behavior in Anorexia Nervosa

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).

Inclusion Criteria:

1. DSM-IV-TR™ diagnosis of anorexia nervosa (restricting or binge-purge subtype), with
or without amenorrhea at the time of inpatient admission.

2. Older than 18

3. No acute medical condition

4. Participation in inpatient treatment

5. Subjects must have signed informed consent document indicating that they understand
the purpose of and procedures required for the study and are willing to participate
in the study.

Exclusion Criteria:

1. Psychotic or bipolar I disorder

2. Substance abuse or dependence in the last 6 months

3. Current Axis I disorder requiring psychotropic medication (subjects taking a stable
dose of psychiatric medications will be allowed.)

4. Active suicidal intent.