Recruitment

Recruitment Status
Completed
Estimated Enrollment
48

Inclusion Criterias

BMI between 30-40kg/m2
Pulse <95 beats per minute
Stable weight (+5 lbs) for a minimum of 3 months
...
BMI between 30-40kg/m2
Pulse <95 beats per minute
Stable weight (+5 lbs) for a minimum of 3 months
English language proficiency
Systolic Blood Pressure <140mm Hg
Diastolic Blood Pressure <90 mm Hg

Exclusion Criterias

Uncontrolled diabetes mellitus (type I or II)
On any antidepressant medications,especially monoamine oxidase inhibitors(MAOI)
Indwelling metallic object (e.g., pacemaker,pump), non-removable metal jewelry, medicinal patch or recent metallic ink tattoo
...
Uncontrolled diabetes mellitus (type I or II)
On any antidepressant medications,especially monoamine oxidase inhibitors(MAOI)
Indwelling metallic object (e.g., pacemaker,pump), non-removable metal jewelry, medicinal patch or recent metallic ink tattoo
Waist circumference greater than 188cm
Known history of learning disorder or developmental disability
History of neurological disorder (e.g. dementia)
Current or past history of kidney disease
Current of past history of congestive heart failure
Current or past history of coronary artery disease
Hypo- or hyper-thyroidism not adequately treated
Current or past history of stroke or transient ischemic attack
Pregnancy, planning to become pregnant, or lactation within the previous 6 months
Current or past history of anorexia nervosa,bulimia nervosa (within the past 12 months) or binge eating disorder (within the previous 6 months)
Current or past history (past 12 months) of alcohol or drug abuse or dependence
Current or past history (lifetime) of amphetamine abuse or dependence
Current or past history of liver disease
Current or past history of peripheral artery disease
On medications (prescribed or OTC) known to affect appetite (e.g. diet pills), weight, or metabolism
History of moderate or severe head injury
Current or past Attention Deficit Hyperactivity Disorder (ADHD)
Significant claustrophobia
Current or past history (within the past 12 months) of major depression
Narrow-angle glaucoma
Prior adverse reaction to phentermine
Current or past history of heart arrhythmias
Previous unsuccessful trial of phentermine

Summary

Conditions
Obesity
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 60 years
Gender
Both males and females

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 study medication for three weeks: one week of phentermine and two weeks of placebo. At the end of the ...

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 study medication for three weeks: one week of phentermine and two weeks of placebo. At the end of the first and third weeks, participants will be asked to participate in a range of eating behavior studies. Following this three-week, double-blind phase, participants will be offered 6 months of open treatment for weight loss.

Inclusion Criterias

BMI between 30-40kg/m2
Pulse <95 beats per minute
Stable weight (+5 lbs) for a minimum of 3 months
...
BMI between 30-40kg/m2
Pulse <95 beats per minute
Stable weight (+5 lbs) for a minimum of 3 months
English language proficiency
Systolic Blood Pressure <140mm Hg
Diastolic Blood Pressure <90 mm Hg

Exclusion Criterias

Uncontrolled diabetes mellitus (type I or II)
On any antidepressant medications,especially monoamine oxidase inhibitors(MAOI)
Indwelling metallic object (e.g., pacemaker,pump), non-removable metal jewelry, medicinal patch or recent metallic ink tattoo
...
Uncontrolled diabetes mellitus (type I or II)
On any antidepressant medications,especially monoamine oxidase inhibitors(MAOI)
Indwelling metallic object (e.g., pacemaker,pump), non-removable metal jewelry, medicinal patch or recent metallic ink tattoo
Waist circumference greater than 188cm
Known history of learning disorder or developmental disability
History of neurological disorder (e.g. dementia)
Current or past history of kidney disease
Current of past history of congestive heart failure
Current or past history of coronary artery disease
Hypo- or hyper-thyroidism not adequately treated
Current or past history of stroke or transient ischemic attack
Pregnancy, planning to become pregnant, or lactation within the previous 6 months
Current or past history of anorexia nervosa,bulimia nervosa (within the past 12 months) or binge eating disorder (within the previous 6 months)
Current or past history (past 12 months) of alcohol or drug abuse or dependence
Current or past history (lifetime) of amphetamine abuse or dependence
Current or past history of liver disease
Current or past history of peripheral artery disease
On medications (prescribed or OTC) known to affect appetite (e.g. diet pills), weight, or metabolism
History of moderate or severe head injury
Current or past Attention Deficit Hyperactivity Disorder (ADHD)
Significant claustrophobia
Current or past history (within the past 12 months) of major depression
Narrow-angle glaucoma
Prior adverse reaction to phentermine
Current or past history of heart arrhythmias
Previous unsuccessful trial of phentermine

Locations

New York, New York, 10032
New York, New York, 10032

Tracking Information

NCT #
NCT01886937
Collaborators
AstraZeneca
Investigators
  • Principal Investigator: Laurel Mayer, MD Columbia University Medical Center/New York State Psychiatric Institute
  • Laurel Mayer, MD Columbia University Medical Center/New York State Psychiatric Institute