Conditions: Bulimia
Keywords: Eating Food Intake Appetite
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 40
Healthy volunteers: yes

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: 'Instructions to eat normally' Placebo 1 mg dose arm 2: 'Instructions to eat normally' drug 1 mg dose 'GSKI181771X (CCK-1R agonist)' arm 3: 'Instructions to eat normally' 2 mg placebo arm 4: 'Instructions to eat normally' 2 mg drug 'GSKI181771X (CCK-1R agonist)' arm 5: 'Instructions to eat normally' 4 mg placebo arm 6: 'Instructions to eat normally' 4 mg drug 'GSKI181771X (CCK-1R agonist)' arm 7: Instructions to binge eat 4 mg placebo arm 8: Instructions to binge eat 4 mg drug 'GSKI181771X (CCK-1R agonist)'

Interventions: intervention 1: GSKI181771X (CCK-1R agonist) intervention 2: Instructions to binge eat intervention 3: Instructions to eat normally intervention 4: Placebo
Intervention descriptions: intervention 1: Drug one trial vs placebo intervention 2: Subjects will be instructed to binge eat and will also be given either drug or placebo intervention 3: Subjects will be instructed to eat normally and will also be given either drug or placebo intervention 4: Drug one trial vs placebo

Protocol document: