- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01172210
Examining Common Substrates of Eating and Alcohol Use Disorders
20. august 2014 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
61
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New York
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New York, New York, Forenede Stater, 10032
- New York State Psychiatric Institute
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 45 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Participants who call the main clinic line at the Eating Disorders Research Unit at NYSPI/CUMC.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Kohorter og interventioner
Gruppe / kohorte |
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Sund kontrol
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Bulimia Nervosa
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Bulimia Nervosa w/ Alcohol Use Disorder
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Eating Behavior
Tidsramme: Baseline
|
Baseline
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Robyn Sysko, Ph.D., New York State Psychiatric Institute
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2009
Primær færdiggørelse (Faktiske)
1. juni 2014
Studieafslutning (Faktiske)
1. juni 2014
Datoer for studieregistrering
Først indsendt
28. juli 2010
Først indsendt, der opfyldte QC-kriterier
28. juli 2010
Først opslået (Skøn)
29. juli 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
21. august 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. august 2014
Sidst verificeret
1. april 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- #5973/6951R
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .