Studying the Effects of Phentermine on Eating Behavior

New York State Psychiatric Institute

Status and phase: Completed; Phase 4

Conditions: Obesity

Treatments: Drug: placebo; Drug: Phentermine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01886937

6415

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

13 participants in 2 patient groups, including a placebo group

37.5 mg Phentermine daily for 7 days

Experimental group

Description:

In this arm, participants receive 37.5mg phentermine for one week followed by 2 weeks of placebo. Other names for phentermine: adipex ionamin

Treatment:

Drug: Phentermine

Placebo (for phentermine 37.5mg)

Placebo Comparator group

Description:

In this arm, participants receive Placebo (for 37.5mg phentermine) for two weeks followed by phentermine 37.5mg for 7 days.

Treatment:

Drug: placebo