Examining Common Substrates of Eating and Alcohol Use Disorders
Primary Purpose
Bulimia Nervosa, Alcohol Use Disorders
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Bulimia Nervosa
Eligibility Criteria
Inclusion Criteria:
- Age 18-45
- Diagnosis of bulimia nervosa with or without a co-occurring alcohol use disorder
- English speaking
- Weight above 80% of ideal
Exclusion Criteria:
- Other significant psychiatric conditions requiring treatment or a significant medical condition
- Pregnancy
- Current use of psychotropic medication
- History of neurological disorder (e.g., dementia, stroke seizure)
- Food allergy to items in the lunch buffet
- Positive urine drug screen
- Current or post eating disorder diagnosis or history of binge eating or vomiting
- Current or past alcohol or substance abuse or dependence
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Arm Label
Bulimia Nervosa
Bulimia Nervosa w/ Alcohol Use Disorder
Healthy Controls
Arm Description
Outcomes
Primary Outcome Measures
Eating Behavior
Secondary Outcome Measures
Full Information
NCT ID
NCT01172210
First Posted
July 28, 2010
Last Updated
August 20, 2014
Sponsor
New York State Psychiatric Institute
1. Study Identification
Unique Protocol Identification Number
NCT01172210
Brief Title
Examining Common Substrates of Eating and Alcohol Use Disorders
Official Title
Examining Common Substrates of Eating and Alcohol Use Disorders
Study Type
Observational
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A substantial percentage of individuals with bulimia nervosa (BN) also meet criteria for a co-occurring substance use disorder, such as alcohol abuse or dependence; however, research examining this sub-group of patients with BN is limited. Understanding characteristics common to both eating and alcohol use disorders may enhance understanding of the mechanisms that could contribute to the co-occurrence and perpetuation of these disorders. Individuals with BN and alcohol use disorders appear to share some behavioral traits, and therefore, the primary aim of the current study is to compare patients with BN with and without an alcohol use disorder and normal controls on measures assessing an individual's mood and ability to perform certain tasks. Participants will be asked to complete computer-administered and paper-and-pencil assessments and two laboratory test meals on separate days. By probing the underpinnings of BN and alcohol use disorders, the investigators can determine whether these disorders have a shared diathesis, which will lay an essential foundation for future research to examine biological and genetic correlates of these disorders. Finally, as little is known about the treatment of patients with BN and a co-occurring alcohol use disorder, an exploratory aim of the current study is evaluate the suitability and efficacy of a 20-session cognitive-behavioral treatment (CBT) addressing both bulimic symptoms and alcohol use.
Detailed Description
A substantial percentage of individuals with bulimia nervosa (BN) also meet criteria for a co-occurring substance use disorder, such as alcohol abuse or dependence; however, research examining this sub-group of patients with BN is limited. Understanding characteristics common to both eating and alcohol use disorders may enhance our understanding of the mechanisms that could contribute to the co-occurrence and perpetuation of these disorders. The primary aim of the current study is to compare patients with BN with and without an alcohol use disorder and normal controls on computer-administered and paper-and-pencil assessments and in two laboratory test meals (a binge meal and a normal meal) on separate days. Participants will also complete self-report and interview measures of eating disorder symptoms and alcohol consumption. By probing the underpinnings of BN and alcohol use disorders, we can determine whether these disorders have a shared diathesis, which will lay an essential foundation for future research to examine biological and genetic correlates of these disorders. Finally, as little is known about the treatment of patients with BN and a co occurring alcohol use disorder, an exploratory aim of the current study is to evaluate the suitability and efficacy of a 20-session cognitive-behavioral treatment (CBT) addressing both bulimic symptoms and alcohol use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa, Alcohol Use Disorders
7. Study Design
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bulimia Nervosa
Arm Title
Bulimia Nervosa w/ Alcohol Use Disorder
Arm Title
Healthy Controls
Primary Outcome Measure Information:
Title
Eating Behavior
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18-45
Diagnosis of bulimia nervosa with or without a co-occurring alcohol use disorder
English speaking
Weight above 80% of ideal
Exclusion Criteria:
Other significant psychiatric conditions requiring treatment or a significant medical condition
Pregnancy
Current use of psychotropic medication
History of neurological disorder (e.g., dementia, stroke seizure)
Food allergy to items in the lunch buffet
Positive urine drug screen
Current or post eating disorder diagnosis or history of binge eating or vomiting
Current or past alcohol or substance abuse or dependence
Study Population Description
Participants who call the main clinic line at the Eating Disorders Research Unit at NYSPI/CUMC.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robyn Sysko, Ph.D.
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Links:
URL
http://columbiaeatingdisorders.org/
Description
Related Info
Learn more about this trial
Examining Common Substrates of Eating and Alcohol Use Disorders
We'll reach out to this number within 24 hrs