Studying the Effects of Phentermine on Eating Behavior

NCT ID: NCT01886937

Last Updated: 2017-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-06-30

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.

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Phentermine

Intervention Type: DRUG

After 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo.

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: 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.

Interventions

Phentermine

After 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

adipex; ionamin; sugar pill

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurel Mayer, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University Medical Center/New York State Psychiatric Institute

Locations

The New York State Psychiatric Institute at Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

6415

Identifier Type: -

Identifier Source: org_study_id