The ultimate aim of this study is to test the hypothesis that the oral cholecystokinin (CCK) agonist GSKI181771X will reduce the size of a binge meal among individuals with Bulimia Nervosa. The study will be conducted in phases. First, an effective dose for reducing food intake, when normal subjects eat normally will be attained. Next, it will be determined whether intake at this dose is reduced in control subjects instructed to eat to capacity. If the dose is still effective compared to placebo, the same dose will be tested in patients with bulimia nervosa.
This study tests the hypothesis that an oral CCK antagonist GSKI181771X will reduce the size of a binge meal. It was intended to study the effects of increasing doses on antagonist on normal individuals to find an effective dose in a non-binge meal before moving to a binge meal. Once the effects of the antagonist on a binge meal were found, the compound would be used on patients with bulimia nervosa. However, the product expired and more was not available before the patients were tested. Data are presented for the normal participants who were instructed to eat normally, followed by a group that was instructed to binge eat. Comparisons were made between groups with different instructions and between binge and normal meals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
40
Drug one trial vs placebo
Subjects will be instructed to binge eat and will also be given either drug or placebo
Subjects will be instructed to eat normally and will also be given either drug or placebo
St. Luke's/Roosevelt Hospital
New York, New York, United States
Food Intake for 4 mg Dose of CCK Agonist vs Placebo Meal Conditions
Food Intake at 25-30 min after having drug or placebo under normal and binge eating instructions
Time frame: 25-30 min after taking drug
Fullness Rating
rating of "How full do you feel" by marking the feeling on a 150 mm line anchored at one end from 0 (not at all) to 150 (most imaginable).
Time frame: 25-30 min after taking drug
Sickness Report
Response to question "How sick do you feel" measured on a 150 mm line anchored by none at all (0 mm left end) and extremely (150 mm right end)
Time frame: 25-30 min after drug or placebo
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Drug one trial vs placebo