Acute Alcohol Response In Bipolar Disorder: a fMRI Study

Part of paid clinical trials in Austin, Texas.

Sponsor
University of Texas at Austin
Study ID
NCT04063384
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 26 Years
Healthy Volunteers
Accepted

Interventions

  • alcohol beverage — OTHER
    Participants will be provided alcohol during study visits and changes in behavior/neural activity after consuming alcohol will be examined.
  • Placebo beverage — OTHER
    placebo beverage conditions.

Study Details

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.

Key Dates

Start date
Jul 22, 2019
Status verified
Nov 2025
Primary completion
Mar 31, 2024
Completion
Mar 31, 2024

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Active Comparator: Alcohol
    Participants will be dosed to a 0.08g% blood alcohol concentration.
  • Placebo Comparator: Placebo
    Participants will receive a low dose of alcohol (placebo condition).

Primary Outcome Measure

Level of Intoxication (Subjective Response) on Each Condition Day After Drinking Relative to How They Felt When Arriving to the Lab on That Respective Day )Prior to Drinking) [ Time Frame: up to 1 week ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas at AustinAustinTexas78712-

Find similar trials in Austin, TX

By condition
Substance use disorderBipolar disorder
By specialty
Behavioral healthAddiction medicinePsychiatryMental health
By research site
University of Texas at Austin· Austin, TX

Related Studies