Obesity
Conditions
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.
Interventions
DRUGPhentermine
After 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo.
DRUGplacebo
Food intake as measured by a laboratory study should be greater after 7 days of placebo administration compared to seven days of phentermine administration.
Sponsors
AstraZeneca
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Food Intake | 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. |
Countries
United States
Participant flow
Recruitment details
37 patients were screened for eligibility between July 2012 and July 2013 at an academic medical center in New York City, NY.
Pre-assignment details
13 of the 37 participants were randomized. Of those not randomized, 18 did not meet inclusion criteria and 6 chose not to participate.
Participants by arm
| Arm | Count |
|---|---|
| 37.5 mg Phentermine First, Then Placebo In this arm, participants receive 37.5mg phentermine for one week followed by 2 weeks of placebo.
Other names for phentermine:
adipex ionamin
Phentermine: After 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo. | 7 |
| Placebo First, Then 37.5mg Phentermine In this arm, participants receive Placebo (for 37.5mg phentermine) for two weeks followed by phentermine 37.5mg for 7 days.
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. | 6 |
| Total | 13 |
Baseline characteristics
| Characteristic | 37.5 mg Phentermine First, Then Placebo | Placebo First, Then 37.5mg Phentermine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 6 Participants | 13 Participants |
| Age, Continuous | 45 years STANDARD_DEVIATION 14 | 37 years STANDARD_DEVIATION 16 | 42 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 5 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants | 4 Participants |
| Region of Enrollment United States | 7 participants | 6 participants | 0 participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 13 | 8 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
Primary
Food Intake
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.
Time frame: one week
Population: This is a cross over design study. All participants received phentermine and placebo.The phentermine arm listed here includes all participants who received phentermine (regardless of whether they received it first or second). The placebo arm includes all those who received placebo (regardless of whether they received placebo first or second).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 37.5 mg Phentermine Daily for 7 Days | Food Intake | 849 kcal | Standard Deviation 572 |
| Placebo (for Phentermine 37.5mg) | Food Intake | 975 kcal | Standard Deviation 504 |
p-value: 0.26t-test, 2 sided