Obesity | Studying the Effects of Phentermine on Eating Behavior
Obesity research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:PhentermineAfter 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo.
Drug:placeboFood intake as measured by a laboratory study should be greater after 7 days of placebo administration compared to seven days of phentermine administration.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
37.5 mg Phentermine daily for 7 daysIn this arm, participants receive 37.5mg phentermine for one week followed by 2 weeks of placebo. Other names for phentermine: adipex ionamin
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.
Start Date: July 2012
Completed Date: June 2014
Phase: Phase 4
Primary Outcome: Food Intake
Study sponsors, principal investigator, and references
Principal Investigator: Laurel Mayer, MD
Lead Sponsor: New York State Psychiatric Institute