NCT04716036Befejeződött
Familial Risk for Bipolar Disorder and Alcohol Sensitivity
Dissecting Responses to Alcohol in Individuals With Familial Risk for Bipolar Disorder
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2024. júl. 24.
Rövid összefoglaló (regiszter, angolul)
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 alcohol biosensor technology to investigate responses to alcohol, compared to placebo, and relationship with parental risk for alcohol use disorders and/or bipolar disorder in young adults. Baseline clinical, cognitive, and behavioral assessments will be completed in 100 young adults (21-26 years; 50% women, no history of AUDs\>mild). Participants would be equally divided among those with parental history of bipolar disorder but not AUDs, parental history of bipolar disorder and AUDs, parental history of AUDs but not bipolar disorder, and typically developing age- and sex-matched controls with no parental history of mood disorders or AUDs (N=25 per group). Then, while wearing Secure Continuous Remote Alcohol Monitoring \[SCRAM\] sensors, participants will complete within-person, counter-balanced, beverage sessions (following standard beverage administration procedures) in a simulated bar laboratory. Changes in heart rate, body sway and subjective self-report measurements of intoxication will also be completed while under the influence of alcohol or placebo. Specifically, individual differences in transdermal alcohol concentration (the primary data output from SCRAM sensors), physiological changes (e.g. heart rate), and the experience of stimulating, sedative, and anxiolytic effects of alcohol (measured with self-report surveys) will be investigated and differences between parental risk subgroups and healthy comparison participants investigated. Differences in transdermal alcohol concentration collected while under the influence of alcohol will be the primary data outcome assessed. Changes in heart rate, body sway, and experience of stimulating, sedative, and anxiolytic effects (from self-report survey data) while under the influence of alcohol compared to placebo session will also be investigated. Additionally, associations between objective and subjective responses to alcohol and drinking patterns will be explored (secondary outcome). 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
- 68 (tényleges)
- Első benyújtás
- 2021. jan. 12.
- Kezdés
- 2021. máj. 13.
- Elsődleges befejezés
- 2024. ápr. 30.
- Fő szponzor
- University of Texas at Austin
- Betegségek
- Bipoláris zavar
- NCT-szám
- NCT04716036
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 68
- 2021. máj. 13. és az elsődleges befejezés (2024. ápr. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- any prior psychiatric hospitalizations
- greater than 1 month of lifetime psychotropic medication
Más betegség
- history of manic episode
- history of psychosis
- history of significant medical illness, particularly if possible changes in cerebral tissue
- history of cannabis use disorder\>moderate over past year
- history of AUD\>mild over lifetime
- 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 substance use disorder (other than alcohol, cannabis, or nicotine) over the past year
- Additional exclusion criteria for familial risk for bipolar disorder participants:
- \- not taking medications for \>4 weeks (i.e. participants must be stable on antidepressant or anti-anxiety medication)
- Additional exclusion criteria for healthy comparison subjects also include:
- lifetime history of a neurodevelopmental disorder, affective disorder, psychotic disorder, eating disorder
- having a parent diagnosed with a mood disorder or AUD
Egyéb
- For all subjects exclusion criteria include:
- full Scale IQ \<85
- 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
- a flushing response (possibly suggesting altered alcohol metabolism)
- reporting never consuming 4 (men) or 3 (women) or more drinks on a single occasion at least twice 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 at least twice over the last year
- euthymic at the time of study
- \- having at least one parent diagnosed with bipolar disorder type I, confirmed by family history interview
- having at least one parent diagnosed with bipolar disorder type I, confirmed by family history interview
- having at least one parent diagnosed with an alcohol use disorder, confirmed by family history interview
- \- having at least one parent diagnosed with an alcohol use disorder, confirmed by family history 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 Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Austin | Egyesült Államok | Ismeretlen állapot |
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