Studying the Effects of Phentermine on Eating Behavior

The Quantification of Ingestive Behavior

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Phentermine; Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • The New York State Psychiatric Institute at Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 37.5 mg Phentermine daily for 7 days; In this arm, participants receive 37.5mg phentermine for one week followed by 2 weeks of placebo. Other names for phentermine: adipex ionamin	Drug: Phentermine; After 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo.; Other Names: adipex; ionamin
PLACEBO_COMPARATOR: Placebo (for phentermine 37.5mg); In this arm, participants receive Placebo (for 37.5mg phentermine) for two weeks followed by phentermine 37.5mg for 7 days.	Drug: placebo; Food intake as measured by a laboratory study should be greater after 7 days of placebo administration compared to seven days of phentermine administration.; Other Names: sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food Intake	The primary outcome measure is food intake assessed by laboratory meal study after one week of phentermine administration compared to one week of placebo administration.	one week

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: June 24, 2013
• First Submitted That Met QC Criteria: June 24, 2013
• First Posted (ESTIMATE): June 26, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2017
• Last Update Submitted That Met QC Criteria: July 3, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Appetite Depressants; Anti-Obesity Agents; Central Nervous System Stimulants; Sympathomimetics; Phentermine
• Other Study ID Numbers: 6415

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO