Studying the Effects of Phentermine on Eating Behavior

• ClinicalTrials.gov Identifier: NCT01886937
• Recruitment Status: Completed
• First Posted: June 26, 2013
• Results First Posted: July 31, 2017
• Last Update Posted: July 31, 2017
• Sponsor: New York State Psychiatric Institute
• Collaborator: AstraZeneca
• Information provided by (Responsible Party): New York State Psychiatric Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obesity	Drug: Phentermine; Drug: placebo	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: The Quantification of Ingestive Behavior
• Study Start Date: July 2012
• Actual Primary Completion Date: June 2014
• Actual Study Completion Date: June 2014

Arms and Interventions

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 Name: sugar pill

Outcome Measures

Primary Outcome Measures :

1. Food Intake [ Time Frame: one week ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

United States, New York

The New York State Psychiatric Institute at Columbia University Medical Center

New York, New York, United States, 10032

Sponsors and Collaborators

New York State Psychiatric Institute

AstraZeneca

Investigators

• Principal Investigator: Laurel Mayer, MD; Columbia University Medical Center/New York State Psychiatric Institute

More Information

• Responsible Party: New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT01886937
• Other Study ID Numbers: 6415
• First Posted: June 26, 2013
• Results First Posted: July 31, 2017
• Last Update Posted: July 31, 2017
• Last Verified: June 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Phentermine; Central Nervous System Stimulants; Physiological Effects of Drugs; Appetite Depressants; Anti-Obesity Agents; Sympathomimetics; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action