Familial Risk for Bipolar Disorder and Alcohol Sensitivity

NCT04716036 | Completed

• 1 other identifier: R21AA027884
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar Disorder; Alcohol Drinking; Alcohol Use Disorder

Outcome Measures

Primary Outcomes (7)

• Changes in transdermal alcohol concentration: time to peak TAC

  Changes in transdermal alcohol concentration (TAC) during the alcohol session (i.e. time to reach peak TAC \[measured in minutes\]) will be compared between subgroups. Study participation to collect data (baseline clinical assessment, alcohol and placebo beverage sessions) should not take more than 13 hours. Participants will wear SCRAM sensors overnight following their alcohol session and return the following morning for SCRAM sensor removal (which takes \<15 minutes).

  up to 24 hours

• Changes in transdermal alcohol concentration: peak TAC experienced

  Changes in transdermal alcohol concentration (TAC) during the alcohol session (i.e. peak TAC \[g/dL\]) will be compared between subgroups. Study participation to collect data (baseline clinical assessment, alcohol and placebo beverage sessions) should not take more than 13 hours. Participants will wear SCRAM sensors overnight following their alcohol session and return the following morning for SCRAM sensor removal (which takes \<15 minutes).

  up to 24 hours

• Changes in transdermal alcohol concentration: area under the curve (AUC)

  Changes in transdermal alcohol concentration (TAC) during the alcohol session (i.e. geometric area under the curve \[AUC\]) will be compared between subgroups. Study participation to collect data (baseline clinical assessment, alcohol and placebo beverage sessions) should not take more than 13 hours. Participants will wear SCRAM sensors overnight following their alcohol session and return the following morning for SCRAM sensor removal (which takes \<15 minutes). The units of the AUC are the units of the Y axis times units of the X axis. Y axis measures transdermal alcohol concentration in g/dL and the X axis measures time in minutes. The area is therefore expressed in units of (g/dL) x minutes.

  up to 24 hours

• Changes in transdermal alcohol concentration: absorption and elimination rates (g/dL per hour)

  Changes in transdermal alcohol concentration (TAC) during the alcohol session (i.e. absorption and elimination rates\[g/dL per hour\]) will be compared between subgroups. Study participation to collect data (baseline clinical assessment, alcohol and placebo beverage sessions) should not take more than 13 hours. Participants will wear SCRAM sensors overnight following their alcohol session and return the following morning for SCRAM sensor removal (which takes \<15 minutes). Absorption rate is calculated as peak TAC (g/dL) divided by the time it took to rise from .000 to the peak; elimination rate is calculated as peak TAC divided by the time it took to decline from peak to .000 again.

  up to 24 hours

• Change (peak BrAC minus baseline BrAC) in heart rate will be compared between alcohol and placebo sessions.

  Participants will have heart rate (beats per minute) measured they first arrive to both beverage administration sessions (alcohol and placebo). They will then have heart rate collected again during their beverage sessions (alcohol and placebo) at target BrACs (i.e, .08g%). Changes in heart rate will be calculated for both the alcohol and placebo conditions (i.e. at peak BrAC minus baseline BrAC) and compared.

  up to 6 hours for alcohol session and up to 6 hours for placebo session

• Change (peak BrAC minus baseline BrAC) in body sway will be compared between alcohol and placebo sessions.

  Participants will body sway measured when they first arrive to both beverage administration sessions (alcohol and placebo). They will then have body sway measured during their beverage sessions (alcohol and placebo) at target BrAC (.08g%). Changes in body sway will be calculated for both the alcohol and placebo conditions (i.e. at peak BrAC minus baseline BrAC) and compared.

  up to 6 hours for alcohol session and up to 6 hours for placebo session

• Change (peak BrAC minus baseline BrAC) in behavior (self-report surveys) will be compared between alcohol and placebo sessions.

  Participants will fill out self-report surveys (i.e., subjective effects of alcohol scale, drug effects questionnaire) on how they feel when they first arrive to both beverage administration sessions (alcohol and placebo). They will then fill out the same self-report surveys on how intoxicated they feel during their beverage sessions (alcohol and placebo) at target BrACs (i.e., .08g%). Changes in how intoxicated they feel will be calculated for both the alcohol and placebo conditions (i.e. at peak BrAC minus baseline BrAC) and compared.

  up to 6 hours for alcohol session and up to 6 hours for placebo session

Secondary Outcomes (4)

• Recent alcohol use patterns relations with variability in transdermal alcohol concentration: time to reach peak TAC

  baseline

• Recent alcohol use patterns relations with variability in transdermal alcohol concentration: peak TAC

  baseline

• Recent alcohol use patterns relations with variability in transdermal alcohol concentration: area under the curve (AUC)

  baseline

• Recent alcohol use patterns relations with variability in transdermal alcohol concentration: absorption and elimination rates

  baseline

Study Arms (2)

Alcohol

ACTIVE COMPARATOR

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

Other: Alcohol beverage

Placebo

PLACEBO COMPARATOR

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

Other: Placebo beverage

Interventions

Alcohol beverage OTHER

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

Alcohol

Placebo beverage OTHER

placebo beverage condition.

Placebo

Eligibility Criteria

• Age: 21 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• history of manic episode
• history of psychosis
• history of significant medical illness, particularly if possible changes in cerebral tissue
• full Scale IQ \<85
• positive pregnancy test
• 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)
• 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
• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Alcohol Drinking; Alcoholism

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Drinking Behavior; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Elizabeth Lippard, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 20, 2021
• Study Start: May 13, 2021
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: We will complete all our analyses and publish results and methodologies in scientific journals before the data are available to the research community. Data will be made available following 6 months after publication.
• Access Criteria: We will be collecting identifying information. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Locations

US (1)