- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01172210
Examining Common Substrates of Eating and Alcohol Use Disorders
August 20, 2014 updated by: New York State Psychiatric Institute
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
61
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- New York State Psychiatric Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants who call the main clinic line at the Eating Disorders Research Unit at NYSPI/CUMC.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Cohorts and Interventions
Group / Cohort |
|---|
|
Healthy Controls
|
|
Bulimia Nervosa
|
|
Bulimia Nervosa w/ Alcohol Use Disorder
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Eating Behavior
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Robyn Sysko, Ph.D., New York State Psychiatric Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
July 28, 2010
First Submitted That Met QC Criteria
July 28, 2010
First Posted (Estimate)
July 29, 2010
Study Record Updates
Last Update Posted (Estimate)
August 21, 2014
Last Update Submitted That Met QC Criteria
August 20, 2014
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #5973/6951R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bulimia Nervosa
-
University of California, San DiegoActive, not recruitingAnorexia Nervosa | Bulimia Nervosa | Atypical Anorexia Nervosa | Atypical Bulimia NervosaUnited States
-
Istituto Auxologico ItalianoCatholic University of the Sacred Heart; University of Turin, Italy; Open University and other collaboratorsRecruitingAnorexia Nervosa/BulimiaItaly
-
University Hospital, ToulouseUnknownAnorexia Nervosa/BulimiaFrance
-
Maastricht UniversityZonMw: The Netherlands Organisation for Health Research and Development; Utrecht... and other collaboratorsRecruitingAnorexia Nervosa | Bulimia Nervosa | Atypical Anorexia Nervosa (Other Specified Eating Disorder) | Atypical Bulimia Nervosa (Other Specified Eating Disorder)Netherlands
-
University of California, San DiegoRecruitingAnorexia Nervosa | Bulimia NervosaUnited States
-
University of California, San DiegoRecruitingAnorexia Nervosa | Bulimia NervosaUnited States
-
Washington University School of MedicineNational Institute of Mental Health (NIMH)Completed
-
Rosemary Claire RodenChildren's Miracle NetworkTerminatedBulimia Nervosa | Impulsive Behavior | Purging (Eating Disorders) | Eating Disorders | Eating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa, Binge Eating/Purging TypeUnited States
-
Yeshiva UniversityYale UniversityCompletedAnorexia Nervosa | Bulimia Nervosa | Anorexia Nervosa, Atypical | Bulimia; AtypicalUnited States
-
Centre Hospitalier EsquirolNot yet recruitingAnorexia Nervosa | Hyperphagia | Eating Disorders | Boulimia NervosaFrance