We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cholecystokinin for Reducing Binge Eating in People With Bulimia Nervosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00308776
Recruitment Status : Terminated (Unable to recruit subjects)
First Posted : March 30, 2006
Last Update Posted : May 28, 2012
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study will determine the effectiveness of administrating a dose of cholecystokinin during a binge eating episode in reducing this eating behavior in people with bulimia nervosa.

Condition or disease Intervention/treatment Phase
Bulimia Nervosa Eating Disorders Procedure: Cholecystokinin (CCK) infusion Procedure: Saline infusion Not Applicable

Detailed Description:

Bulimia Nervosa (BN) is a serious eating disorder that is characterized by frequent uncontrolled eating binges. These binges are often followed by compensatory behavior, including the following: self-induced vomiting; misuse of laxatives, diuretics, enemas, or other medications to induce purging; fasting; or excessive exercise. If left untreated, BN can lead to many serious health issues: tooth decay; irregular menstruation; bowel damage; constipation; heart and kidney disease; intestinal damage; puffiness, especially in the face and fingers; increased hair growth on the face and body; and mineral imbalances in the body. Cholecystokinin (CCK) is a hormone that is released by the small intestine, and functions as a trigger for digestion and hunger suppression. People with BN often have disturbances in the release of CCK, which may contribute to their binge eating behavior. This study will determine the effectiveness of administrating a dose of CCK during a binge eating episode in reducing this eating behavior in people with BN.

This study will enroll females with BN and healthy females without BN. Interested participants will first report to the study site for an interview about their feelings on their eating habits. If eligible, participants will report to the study site at 9 A.M. on 4 days. Upon arrival, they will receive a standardized breakfast of apple juice and an English muffin with butter. Participants will then return 2.5 hours later to start an IV and begin infusion with a normal saline solution. After 10 minutes of saline infusion, participants will eat a small bowl of tomato soup, followed 20 minutes later by a 15-minute infusion of either saline or saline plus CCK. Participants will then be given a meal of macaroni and beef. They will be alone in the room while eating, but will be monitored by TV camera. Nothing, however, will be taped or recorded. A tape recording will be used to instruct participants when to begin eating. Participants will be instructed to either eat until an assistant returns to the room, or eat as much as they can. Participants will also fill out questionnaires before and after each meal, and sometimes during a meal. The amount of food consumed after an infusion with CCK will be assessed upon study completion.

For information on related studies, please follow these links:

http://clinicaltrials.gov/show/NCT00307190

http://clinicaltrials.gov/show/NCT00304187

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effect of Cholecystokinin on Binge Eating in Bulimia Nervosa
Study Start Date : October 2003
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Cholecystokinin
Participants will receive intravenous saline plus cholescystokinin.
 Procedure: Cholecystokinin (CCK) infusion
Participants will begin infusion with a normal saline solution. After 10 minutes of saline infusion, participants will eat a small bowl of tomato soup, followed 20 minutes later by a 15-minute infusion of saline plus CCK.
Placebo Comparator: Saline
Participants will receive intravenous saline only.
 Procedure: Saline infusion
Participants will begin infusion with a normal saline solution. After 10 minutes of saline infusion, participants will eat a small bowl of tomato soup, followed 20 minutes later by a 15-minute infusion of saline only.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Amount of food consumed after administration of CCK (measured upon study completion) [ Time Frame: Measured at Day 4 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for Patients with BN:

  • Meets DSM-IV criteria for BN
  • BN duration of more than 1 year
  • Self-induces vomiting
  • Weighs between 80 and 120% of ideal body weight

Exclusion Criteria for Patients with BN:

  • Significant medical illness
  • Current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, as defined by DSM-IV-TR criteria
  • Current DSM-IV-TR diagnosis of organic mental disorder, factitious disorder, or malingering
  • History of a personality disorder (e.g., schizotypal, borderline, or antisocial) that might interfere with the study procedures
  • At risk for suicide, as defined by the expression of an imminent plan or attempt within the 6 months prior to study entry
  • Currently taking psychotropic medications or medications that affect gastrointestinal function
  • Moderate to severe depression, as defined by a score of greater than 28 on the Hamilton Depression Rating Scale
  • Drug or alcohol abuse within the 3 months prior to study entry
  • Pregnant, planning to become pregnant, or lactating
  • Body mass index (BMI) of less than 18 (underweight)

Inclusion Criteria for Normal Weight Controls:

  • No current or past psychiatric history
  • No history of binge eating or vomiting
  • 80-120% of ideal body weight

Exclusion Criteria for Normal Weight Controls:

  • Significant medical illness
  • Current psychotropic medications and current medications that affect GI function
  • Drug or alcohol abuse in last 3 months
  • Pregnancy, planning to become pregnant or laction
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00308776


Locations
Layout table for location information
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: B. Timothy Walsh, MD New York State Psychiatric Institute at Columbia University Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00308776    
Other Study ID Numbers: #4736
DATR A2-AID
First Posted: March 30, 2006    Key Record Dates
Last Update Posted: May 28, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
Layout table for MeSH terms
Bulimia
Feeding and Eating Disorders
Bulimia Nervosa
Mental Disorders
Hyperphagia
 Signs and Symptoms, Digestive
Cholecystokinin
Cholagogues and Choleretics
Gastrointestinal Agents