Studying the Effects of Phentermine on Eating Behavior

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01886937
• Collaborator: AstraZeneca (Industry)
• Enrollment: 13
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: Phentermine; Drug: placebo	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: The Quantification of Ingestive Behavior
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Phentermine; 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 Comparator: 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.	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.; Other Names: sugar pill

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The New York State Psychiatric Institute at Columbia University Medical Center	New York	New York	United States	10032

Sponsors and Collaborators

• New York State Psychiatric Institute
• AstraZeneca

Investigators

• Principal Investigator: Laurel Mayer, MD, Columbia University Medical Center/New York State Psychiatric Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT01886937
• Other Study ID Numbers: 6415
• First Posted: Jun 26, 2013
• Last Update Posted: Jul 31, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Phentermine

Study Results

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 Detail	13 of the 37 participants were randomized. Of those not randomized, 18 did not meet inclusion criteria and 6 chose not to participate.

Arm/Group Title	37.5 mg Phentermine Daily for 7 Days First,Followed by Placebo	Placebo (for Phentermine 37.5mg) First, Followed by Phentermin
Arm/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 Phentermine: After 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo.	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.
Period Title: Overall Study
STARTED	7	6
COMPLETED	7	6
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	37.5 mg Phentermine First, Then Placebo	Placebo First, Then 37.5mg Phentermine	Total
Arm/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 Phentermine: After 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo.	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.	Total of all reporting groups
Overall Participants	7	6	13
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	7 100%	6 100%	13 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45 (14)	37 (16)	42 (14)
Sex: Female, Male (Count of Participants)
Female	6 85.7%	6 100%	12 92.3%
Male	1 14.3%	0 0%	1 7.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 28.6%	1 16.7%	3 23.1%
Not Hispanic or Latino	5 71.4%	5 83.3%	10 76.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 14.3%	1 16.7%	2 15.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 57.1%	3 50%	7 53.8%
White	2 28.6%	2 33.3%	4 30.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	7 100%	6 100%	0 0%

Outcome Measures

1. Primary Outcome

Title	Food Intake
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	37.5 mg Phentermine Daily for 7 Days	Placebo (for Phentermine 37.5mg)
Arm/Group Description	In this arm, participants receive 37.5mg phentermine for one week . 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.	In this arm, participants receive Placebo (for 37.5mg phentermine) 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.
Measure Participants	13	13
Mean (Standard Deviation) [kcal]	849 (572)	975 (504)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	37.5 mg Phentermine Daily for 7 Days, Placebo (for Phentermine 37.5mg)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.26
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	One week for each study intervention (phentermine or placebo).
Arm/Group Title	37.5 mg Phentermine		Placebo
Arm/Group Description	This describes all participants who received 37.5mg phentermine for one week. Other names for phentermine: adipex ionamin		This group refers to all participants who received Placebo.
All Cause Mortality
	37.5 mg Phentermine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	37.5 mg Phentermine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	37.5 mg Phentermine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/13 (69.2%)		8/13 (61.5%)
Cardiac disorders
irregular heartbeat	0/13 (0%)		1/13 (7.7%)
shortness of breath	0/13 (0%)		1/13 (7.7%)
Gastrointestinal disorders
constipation	3/13 (23.1%)		4/13 (30.8%)
nausea	2/13 (15.4%)		1/13 (7.7%)
increased appetite	0/13 (0%)		2/13 (15.4%)
diarrhea	0/13 (0%)		1/13 (7.7%)
decreased appetite	5/13 (38.5%)		3/13 (23.1%)
sour taste	1/13 (7.7%)		0/13 (0%)
General disorders
dry mouth	5/13 (38.5%)		3/13 (23.1%)
Nervous system disorders
headache	2/13 (15.4%)		3/13 (23.1%)
feeling drowsy or sleepy	1/13 (7.7%)		1/13 (7.7%)
trouble concentrating	2/13 (15.4%)		1/13 (7.7%)
tremor	2/13 (15.4%)		1/13 (7.7%)
dizziness	2/13 (15.4%)		1/13 (7.7%)
lightheaded upon standing	2/13 (15.4%)		1/13 (7.7%)
difficulty sleeping	3/13 (23.1%)		4/13 (30.8%)
Renal and urinary disorders
increased urination	2/13 (15.4%)		3/13 (23.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.