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Completed

NCT Number: NCT01886937

Studying the Effects of Phentermine on Eating 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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The New York State Psychiatric Institute at Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Phentermine

Drug

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

Drug

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

The Quantification of Ingestive Behavior

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 26, 2013
Registry last updated
Jul 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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