NCT04063384Befejeződött
Acute Alcohol Response In Bipolar Disorder: a fMRI Study
Subjective Response to Alcohol and Associated Neural Systems in Bipolar Disorder
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 11.
Rövid összefoglaló (regiszter, angolul)
Alcohol use disorders (AUDs) affect up to 60% of individuals with bipolar disorder during their lifetime-a rate 3 to 5 times higher than what occurs in the general population. The mechanisms that contribute to elevated rates of comorbidity are not known. Early identification in individuals with bipolar disorder who are at risk for AUDs could inform novel intervention strategies and improve life-long outcomes. The primary objective of this protocol is to use alcohol administration procedures and functional MRI techniques to investigate subjective response to alcohol, compared to placebo, and relationship with functional responses of, and connectivity among, brain regions in ventral prefrontal emotional networks in young adults with bipolar disorder and healthy comparison young adults. Baseline clinical and structural MRI assessments will be completed in 30 bipolar and 30 healthy young adults (21-26 years of age, 50% women). Then, following standard beverage administration procedures, participants will complete within-person, counter-balanced, fMRI scans and complete measures of subjective response to alcohol while under the influence of alcohol or placebo. Specifically, individual differences in the experience of stimulating, sedative, and anxiolytic effects of alcohol (measured with self-report surveys) and individual differences in neural responses to alcohol within ventral prefrontal emotional networks will be investigated and differences in bipolar disorder compared to healthy participants assessed. Functional MRI scans during a continuous performance task with emotional and neutral distractors (CPT-END) and at rest will be collected while under the influence of alcohol and placebo and compared. Experience of stimulating, sedative, and anxiolytic effects of alcohol from self-report survey data and neural responses to emotional stimuli while under the influence of alcohol compared to placebo will be the primary data outcomes assessed. Additionally, associations between subjective and neural response to alcohol and drinking patterns will be explored (secondary outcomes). The primary endpoint of the study will be after completion of both alcohol and placebo beverage conditions.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 60 (tényleges)
- Első benyújtás
- 2019. aug. 9.
- Kezdés
- 2019. júl. 22.
- Elsődleges befejezés
- 2024. márc. 31.
- Fő szponzor
- University of Texas at Austin
- Betegségek
- Bipoláris zavar
- NCT-szám
- NCT04063384
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 60
- 2019. júl. 22. és az elsődleges befejezés (2024. márc. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- not taking medications for greater than or equal to 4 weeks (i.e. participants must be stable on medications)
- Additional exclusion criteria for healthy comparison subjects also include:
- any prior psychiatric hospitalizations
- greater than 1 month of lifetime psychotropic medication. -
Más betegség
- history of significant medical illness, particularly if possible changes in cerebral tissue
- current cannabis use disorder>moderate
- history of severe AUDs
- scores > 15 on the alcohol Use Disorders Identification Test (AUDIT; part of phone screen)
- history of heart attack, heart trouble, high blood pressure, diabetes, or liver disease
- a past year substance use disorder (other than alcohol, cannabis, or nicotine)
- Additional exclusion criteria for bipolar disorder participants:
- lifetime history of a neurodevelopmental disorder, affective disorder, psychotic disorder, eating disorder
Egyéb
- For all subjects exclusion criteria include:
- neurologic abnormality including significant head trauma (loss of consciousness of ≥5-min)
- full Scale intelligence quotient (IQ) <85
- contraindication to MRI scanning
- positive pregnancy test
- ever being in an abstinence-oriented treatment program for alcohol use
- reporting wanting to quit drinking but not being able to
- any medical, religious, or other reasons for not drinking alcohol
- an adverse reaction to alcoholic beverages
- reporting never consuming 4 (men) or 3 (women) or more drinks on a single occasion over the last year
- unwillingness to have a friend or family member drive them home after the alcohol administration sessions
Kiket keres a vizsgálat
- between 21 and 26 years of age
- having consumed at least 4 (men) or 3 (women) drinks on a single occasion over the last year
- euthymic at the time of study
- Meeting Diagnostic and Statistical Manual-5 Research Version (DSM-V-RV) diagnostic criteria for bipolar disorder, confirmed by structured interview
Életkor a regiszterben: 21 év – 26 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University of Texas at Austin | Austin | Egyesült Államok | Ismeretlen állapot |
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