Bulimia NervosaNCT01172210
Examining Common Substrates of Eating and Alcohol Use Disorders
An observational study of Bulimia Nervosa and Alcohol Use Disorders, run by New York State Psychiatric Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bulimia Nervosa, Alcohol Use Disorders
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants who call the main clinic line at the Eating Disorders Research Unit at NYSPI/CUMC.
Who may be able to join
- Age 18-45
- Diagnosis of bulimia nervosa with or without a co-occurring alcohol use disorder
- English speaking
- Weight above 80% of ideal
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
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.
Read the 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.
- Conditions
- Bulimia Nervosa, Alcohol Use Disorders
- Medical subject headings
- Bulimia Nervosa, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bulimia Nervosa | Not described | |
| Bulimia Nervosa w/ Alcohol Use Disorder | Not described | |
| Healthy Controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Behavior
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startJul 2009
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bulimia NervosaStudies 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
- Observational
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robyn Sysko, Ph.D., Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172210
- Sponsor's protocol ID
- #5973/6951R
- Status last verified
- Apr 2013
- First submitted
- 28 Jul 2010
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Common Substrates of Eating and Alcohol Use Disorders
- ClinicalTrials.gov ID
- NCT01172210
- Acronym / sponsor ID
- #5973/6951R
- Conditions
- Bulimia Nervosa, Alcohol Use Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 29 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bulimia Nervosa | – | – |
| Bulimia Nervosa w/ Alcohol Use Disorder | – | – |
| Healthy Controls | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants who call the main clinic line at the Eating Disorders Research Unit at NYSPI/CUMC.
Key inclusion criteria (4 listed)
- Age 18-45
- Diagnosis of bulimia nervosa with or without a co-occurring alcohol use disorder
- English speaking
- Weight above 80% of ideal
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Eating Behavior
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2014.
- Related InfoLink provided by the sponsor.
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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.
Robyn Sysko, Ph.D. principal investigator
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?
An observational study of Bulimia Nervosa and Alcohol Use Disorders, 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 4 inclusion and 8 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 21 Aug 2014. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Eating Behavior (time frame: Baseline). 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 21 Aug 2014.