Acute Alcohol Response In Bipolar Disorder: a fMRI Study

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-22

Study Completion Date

2024-03-31

Brief Summary

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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.

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COMPLETED EARLY_PHASE1

Detailed Description

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A total of 60 bipolar and healthy comparison subjects (n=30 per group, 21-26 years of age, 50% women, with no history of a moderate/severe AUD) will be recruited from the greater Austin area. Once recruited and enrolled, subjects will undergo detailed structured clinical evaluations to verify inclusion and exclusion criteria, comprehensive assessment of alcohol and other drug use history, and cognitive testing, followed by structural MRI assessments. Following standard beverage administration procedures, they will then complete measures of subjective response to alcohol and fMRI scans while under the influence of alcohol or a placebo condition (counter-balanced). For each participant the first beverage session assignment (whether the participant is given alcohol or the placebo beverage first) will be randomized. Alcohol and placebo sessions will occur within 3 days of each other. FMRI assessments will include a continuous performance task with emotional and neutral distractors (CPT-END) and a resting state scan.

For both the alcohol and the placebo beverage conditions, the protocol will be the same. The beverage administration sessions will occur in a private room at the University of Texas at Austin in the Imaging Research Center. The table in the testing room will be wiped down with alcohol prior to the participant's arrival (olfactory cue). Study staff will use an algorithm to calculate individual alcohol doses based on the participants' age, sex, height, and weight. Participants fast from food for 4 hours prior to their session. Before beginning consumption of their beverages, they will eat a weight-adjusted, 1 calorie per pound snack of pretzels. While participants eat their pretzels, study staff will mix beverages in front of participants. Vodka and placebo (decarbonated tonic water) will be stored in absolute vodka bottles, measured out, and combined with mixer in front of participants. Mixed drinks will be poured into glasses that have been sitting face down with rims soaking in vodka. Prior to giving the beverage to the participant, all drinks will get an alcohol floater (squirt of absolute vodka on top of the drink). Participants will be given 20 minutes to orally consume two beverages (10 minutes per beverage).

Following oral consumption and a 10 minute absorption period, breathalyzer tests will be conducted to identify a .06g% ascending limb breath alcohol concentration (BrAC). Self-report of subjective response to alcohol will be collected and participants will immediately enter the scanner and complete the fMRI scan (acquisition parameters are identical during alcohol and placebo conditions). BrAC will be tracked after the MRI scan and subjective response to alcohol collected again at peak BrAC and at descending BrAC of .06g%. Consistent with NIAAA guidelines for human alcohol studies, BrAC readings will continue every 30 minutes until participants are below 0.04% at which time they will be escorted home. During the placebo condition, participants will be given false BrAC readings. False BrAC readings given to participants during the placebo session will be based on the average BrACs we record during the alcohol sessions. The average time participants stay in the laboratory will be the same for the placebo and alcohol beverage conditions. Participants are debriefed after completing all sessions and the need for deception to ensure the placebo-controlled alcohol session will be explained.

Conditions

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Bipolar Disorder Alcohol Drinking Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Alcohol

Participants will be dosed to a 0.08g% blood alcohol concentration.

Group Type ACTIVE_COMPARATOR

alcohol beverage

Intervention Type OTHER

Participants will be provided alcohol during study visits and changes in behavior/neural activity after consuming alcohol will be examined.

Placebo

Participants will receive a low dose of alcohol (placebo condition).

Group Type PLACEBO_COMPARATOR

Placebo beverage

Intervention Type OTHER

placebo beverage conditions.

Interventions

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alcohol beverage

Participants will be provided alcohol during study visits and changes in behavior/neural activity after consuming alcohol will be examined.

Intervention Type OTHER

Placebo beverage

placebo beverage conditions.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* history of significant medical illness, particularly if possible changes in cerebral tissue
* 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
* current cannabis use disorder\>moderate
* history of severe AUDs
* scores \> 15 on the alcohol Use Disorders Identification Test (AUDIT; part of phone screen)
* 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
* history of heart attack, heart trouble, high blood pressure, diabetes, or liver disease
* 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
* a past year substance use disorder (other than alcohol, cannabis, or nicotine)

\- not taking medications for greater than or equal to 4 weeks (i.e. participants must be stable on medications)

* any prior psychiatric hospitalizations
* lifetime history of a neurodevelopmental disorder, affective disorder, psychotic disorder, eating disorder
* greater than 1 month of lifetime psychotropic medication. -

Minimum Eligible Age

21 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes