NCT01886937

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_4 obesity

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

July 31, 2017

Completed
Last Updated

July 31, 2017

Status Verified

June 1, 2017

Enrollment Period

1.9 years

First QC Date

June 24, 2013

Results QC Date

March 28, 2017

Last Update Submit

July 3, 2017

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • 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.

    one week

Study Arms (2)

37.5 mg Phentermine daily for 7 days

EXPERIMENTAL

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

Placebo (for phentermine 37.5mg)

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

PhentermineDRUG

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

Also known as: adipex, ionamin
37.5 mg Phentermine daily for 7 days
placeboDRUG

Food intake as measured by a laboratory study should be greater after 7 days of placebo administration compared to seven days of phentermine administration.

Also known as: sugar pill
Placebo (for phentermine 37.5mg)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The New York State Psychiatric Institute at Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

PhentermineSugars

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AmphetaminesPhenethylaminesEthylaminesAminesOrganic ChemicalsCarbohydrates

Results Point of Contact

Title
Dr. Laurel Mayer
Organization
New York State Psychiatric Institute
lsm16@cumc.columbia.edu
646-774-8067

Study Officials

  • Laurel Mayer, MD

    Columbia University Medical Center/New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2013

First Posted

June 26, 2013

Study Start

July 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 31, 2017

Results First Posted

July 31, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)