Phase 4 N=13 Randomized Double-blind Other

Studying the Effects of Phentermine on Eating Behavior

Obesity

Bottom Line

View on ClinicalTrials.gov: NCT01886937 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2017

Primary outcome: Primary: Food Intake — 849; 975 kcal — p=0.26

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Phentermine (Drug); placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: New York State Psychiatric Institute
Primary completion: Jun 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Food Intake	849; 975	0.26

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.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01886937). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.