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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01172210
Other study ID # #5973/6951R
Secondary ID
Status Completed
Phase N/A
First received July 28, 2010
Last updated August 20, 2014
Start date July 2009
Est. completion date June 2014

Study information

Verified date April 2013
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility 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 Design

N/A


Locations

Country Name City State
United States New York State Psychiatric Institute New York New York

Sponsors (1)

Lead Sponsor Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Eating Behavior Baseline No
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