ObesityPhase 4NCT01886937
Studying the Effects of Phentermine on Eating Behavior
A Phase 4 study testing Phentermine in people with Obesity, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Phentermine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jun 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The New York State Psychiatric Institute at Columbia University Medical Center
New York, New York, 10032
About this study
Official title: The Quantification of Ingestive Behavior
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.
Read the 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
- Being tested
- Phentermine, placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhentermineDrug
Also called adipex, ionamin
After 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo.
placeboDrug
Also called sugar pill
Food intake as measured by a laboratory study should be greater after 7 days of placebo administration compared to seven days of phentermine administration.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJul 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Laurel Mayer, MD, Principal investigator, Columbia University Medical Center/New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886937
- Sponsor's protocol ID
- 6415
- Status last verified
- Jun 2017
- First submitted
- 24 Jun 2013
- Last updated
- 31 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Quantification of Ingestive Behavior
- ClinicalTrials.gov ID
- NCT01886937
- Acronym / sponsor ID
- 6415
- Conditions
- Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jul 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Jun 2013 (estimated)
- Results
- Posted 31 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 37.5 mg Phentermine daily for 7 days | Experimental | Drug: PhentermineIn 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) | Placebo comparator | Drug: placeboIn this arm, participants receive Placebo (for 37.5mg phentermine) for two weeks followed by phentermine 37.5mg for 7 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhentermineAlso: adipex, ionaminAfter 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo. | Drug | 37.5 mg Phentermine daily for 7 days |
| placeboAlso: sugar pillFood intake as measured by a laboratory study should be greater after 7 days of placebo administration compared to seven days of phentermine administration. | Drug | Placebo (for phentermine 37.5mg) |
Primary outcome
Food Intake
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurel Mayer, MD principal investigator
Columbia University Medical Center/New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phentermine in people with Obesity, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food Intake (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2017.