Studying the Effects of Phentermine on Eating Behavior

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to determine whether one week of phentermine compared to placebo administration results in changes in food intake during a laboratory meal.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: AstraZeneca
• Treatments: Phentermine

Criteria

Inclusion Criteria:

• BMI between 30-40kg/m2

• Stable weight (+5 lbs) for a minimum of 3 months

• Systolic Blood Pressure <140mm Hg

• Diastolic Blood Pressure <90 mm Hg

• Pulse <95 beats per minute

• English language proficiency

Exclusion Criteria:

• Previous unsuccessful trial of phentermine

• Prior adverse reaction to phentermine

• On any antidepressant medications,especially monoamine oxidase inhibitors(MAOI)

• History of neurological disorder (e.g. dementia)

• History of moderate or severe head injury

• Current or past history of coronary artery disease

• Current or past history of stroke or transient ischemic attack

• Current or past history of heart arrhythmias

• Current of past history of congestive heart failure

• Current or past history of peripheral artery disease

• Current or past history of liver disease

• Current or past history of kidney disease

• Uncontrolled diabetes mellitus (type I or II)

• Narrow-angle glaucoma

• Hypo- or hyper-thyroidism not adequately treated

• On medications (prescribed or OTC) known to affect appetite (e.g. diet pills), weight, or metabolism

• Current or past history (within the past 12 months) of major depression

• Current or past history (past 12 months) of alcohol or drug abuse or dependence

• Current or past history (lifetime) of amphetamine abuse or dependence

• Known history of learning disorder or developmental disability

• Current or past Attention Deficit Hyperactivity Disorder (ADHD)

• Pregnancy, planning to become pregnant, or lactation within the previous 6 months

• Waist circumference greater than 188cm

• Indwelling metallic object (e.g., pacemaker,pump), non-removable metal jewelry, medicinal patch or recent metallic ink tattoo

• Significant claustrophobia

• Current or past history of anorexia nervosa,bulimia nervosa (within the past 12 months) or binge eating disorder (within the previous 6 months)