Status:
COMPLETED
Studying the Effects of Phentermine on Eating Behavior
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
AstraZeneca
Conditions:
Obesity
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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.
Detailed Description
This study aims to explore whether short-term measures of eating behavior can be related to later, longer-term weight loss. In a double-blind, randomized fashion, participants will be asked to take st...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01886937
Start Date
July 1 2012
End Date
June 1 2014
Last Update
July 31 2017
Active Locations (1)
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1
The New York State Psychiatric Institute at Columbia University Medical Center
New York, New York, United States, 10032