Conditions: Overweight Obesity
Keywords: Overweight Obesity coordination psychomotor
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 80
Healthy volunteers: yes

Brief summary:
The purpose of this study is to determine how VI-0521 affect speed and reaction time on specific tasks that require eye and hand coordination, compared to placebo.

Detailed description:

Arms:
arm 1: Dosed first with alcohol, then active VI-0521, and last, VI-0521 placebo arm 2: First dosed with alcohol placebo (fruit juice), then active VI-0521, and last, placebo VI-0521 arm 3: First dosed with alcohol, then VI-0521 placebo, and last, active VI-0521 arm 4: First dosed with alcohol placebo, then VI-0521 placebo, and last, active VI-0521

Interventions: intervention 1: VI-0521 intervention 2: Placebo intervention 3: Alcohol intervention 4: alcohol placebo
Intervention descriptions: intervention 1: Phentermine 3.75 mg and topiramate 23 mg daily for the 1st week; Phentermine 7.5 mg and topiramate 46 mg daily for the 2nd week; Phentermine 11.25 mg and topiramate 69 mg daily for the 3rd week; Phentermine 15 mg and topiramate 92 mg daily for the 4th week intervention 2: Placebo daily for 4 weeks intervention 3: None intervention 4: fruit juice

Protocol document: