Clinical trial NCT01886937: Studying the Effects of Phentermine on Eating Behavior
Official title: The Quantification of Ingestive Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2013-06-26
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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 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.

Eligibility 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)

Primary outcomes:
measure: Food Intake
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: The New York State Psychiatric Institute at Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University Medical Center/New York State Psychiatric Institute
name: Laurel Mayer, MD
role: PRINCIPAL_INVESTIGATOR
References: