Bipolar DisorderBACSNCT04063384

Acute Alcohol Response In Bipolar Disorder: a fMRI Study

A study testing alcohol beverage in people with Bipolar Disorder and Alcohol Drinking, run by University of Texas at Austin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 26 yearsHealthy volunteers can take part
Conditions the study is for: Bipolar Disorder, Alcohol Drinking, Alcohol Use Disorder
What is being tested?: alcohol beverage
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 22 Jul 2019to 31 Mar 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 26 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

For all subjects exclusion criteria include:
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

Show all 23Show fewer

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)
Additional exclusion criteria for bipolar disorder participants:
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
lifetime history of a neurodevelopmental disorder, affective disorder, psychotic disorder, eating disorder
greater than 1 month of lifetime psychotropic medication. -

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Texas at Austin
Austin, Texas, 78712

Other trials in United States

About this study

Official title: Subjective Response to Alcohol and Associated Neural Systems in Bipolar Disorder

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.

Read the detailed description

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: Bipolar Disorder, Alcohol Drinking, Alcohol Use Disorder
Being tested: alcohol beverage, Placebo beverage
Medical subject headings: Bipolar Disorder, Alcohol Drinking, Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04063384
Study group	Role	What they receive
Alcohol	Active comparator	Participants will be dosed to a 0.08g% blood alcohol concentration. Receives: Other: alcohol beverage
Placebo	Placebo comparator	Participants will receive a low dose of alcohol (placebo condition). Receives: Other: Placebo beverage

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Participants fill out self-report surveys [specifically the Subjective Effects of Alcohol Scale (SEAS)] on how they feel when they arrive to their beverage administration sessions (alcohol and placebo sessions). They then feel out the same self-report surveys on how intoxicated they feel during their beverage sessions (alcohol and placebo). Changes in how intoxicated they feel is calculated for both the alcohol and placebo condition (compared to how they felt pre-beverage). 4 subscores are calculated by summing individual items: positive valence/positive arousal (stimulation), SEAS positive valence/negative arousal (anxiolytic), negative valence/negative arousal (aggression/agitation), and negative valence/negative arousal (sedative effects). Summed subscores on the SEAS range between 0 and 40. Change scores can therefore range between -40 and 40 (post-beverage compared to pre-beverage feelings). Scores greater than 0 on any one subscale indicates feeling more effects of alcohol.
Measured: up to 1 week
Change in Functional Coupling Between Regions of Interest During Viewing of Emotional Stimuli (Neural Responses While Viewing Emotional Stimuli Were Contrasted Against Neural Responses When Viewing Squares)
Neural responses to emotional stimuli during the alcohol and placebo sessions were modeled. Fisher transformed correlation coefficients between regions of interest while viewing emotional stimuli (compared to squares) were calculated for each beverage session and data extracted for posthoc analysis. Values represent change scores in correlation coefficients during each beverage session.
Measured: up to 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jul 201931 Mar 2024

First posted21 Aug 2019
Study start22 Jul 2019
Primary completion31 Mar 2024
Study completion31 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Bipolar DisorderStudies of the same condition, open and under way.
More trials run by University of Texas at AustinThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04063384
Sponsor's protocol ID: K01AA027573
Acronym: BACS
Status last verified: Nov 2025
First submitted: 9 Aug 2019
Last updated: 11 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: After study completion and publication of finding, functional neuroimaging data and behavior data collected following alcohol and placebo conditions will be shared.

Publications

Kirsch DE, Kosted R, Le V, Almeida JRC, Fromme K, Strakowski SM, Lippard ETC. Ventral prefrontal network response to alcohol in young adults with bipolar disorder: a within-subject randomized placebo-controlled alcohol administration study. Neuropsychopharmacology. 2023 Dec;48(13):1910-1919. doi: 10.1038/s41386-023-01657-6. Epub 2023 Jul 20.
PubMed 37474761
Kosted R, Kirsch DE, Le V, Fromme K, Lippard ETC. Subjective response to alcohol: Interactive effects of early life stress, parental risk for mood and substance use disorders, and drinking context. Pharmacol Biochem Behav. 2023 Aug;229:173591. doi: 10.1016/j.pbb.2023.173591. Epub 2023 Jun 22.
PubMed 37353164
Lippard ETC, Kirsch DE, Kosted R, Le V, Almeida JRC, Fromme K, Strakowski SM. Subjective response to alcohol in young adults with bipolar disorder and recent alcohol use: a within-subject randomized placebo-controlled alcohol administration study. Psychopharmacology (Berl). 2023 Apr;240(4):739-753. doi: 10.1007/s00213-023-06315-9. Epub 2023 Jan 25.
PubMed 36695842
Kirsch DE, Le V, Kosted R, Fromme K, Lippard ETC. Neural underpinnings of expecting alcohol: Placebo alcohol administration alters nucleus accumbens resting state functional connectivity. Behav Brain Res. 2023 Feb 2;437:114148. doi: 10.1016/j.bbr.2022.114148. Epub 2022 Oct 4.
PubMed 36206822

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Subjective Response to Alcohol and Associated Neural Systems in Bipolar Disorder
ClinicalTrials.gov ID: NCT04063384
Acronym / sponsor ID: BACS / K01AA027573
Conditions: Bipolar Disorder, Alcohol Drinking, Alcohol Use Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University of Texas at AustinUniversity, hospital or other
Study start: 22 Jul 2019 (actual)
Primary completion: 31 Mar 2024 (actual)
Study completion: 31 Mar 2024 (actual)
First posted: 21 Aug 2019 (actual)
Results: Posted 19 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Alcohol	Active comparator	Other: alcohol beverageParticipants will be dosed to a 0.08g% blood alcohol concentration.
Placebo	Placebo comparator	Other: Placebo beverageParticipants will receive a low dose of alcohol (placebo condition).

Who may qualify

Ages: 21 to 26 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (23 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
alcohol beverageParticipants will be provided alcohol during study visits and changes in behavior/neural activity after consuming alcohol will be examined.	Other	Alcohol
Placebo beverageplacebo beverage conditions.	Other	Placebo

Primary outcome

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
Participants fill out self-report surveys [specifically the Subjective Effects of Alcohol Scale (SEAS)] on how they feel when they arrive to their beverage administration sessions (alcohol and placebo sessions). They then feel out the same self-report surveys on how intoxicated they feel during their beverage sessions (alcohol and placebo). Changes in how intoxicated they feel is calculated for both the alcohol and placebo condition (compared to how they felt pre-beverage). 4 subscores are calculated by summing individual items: positive valence/positive arousal (stimulation), SEAS positive valence/negative arousal (anxiolytic), negative valence/negative arousal (aggression/agitation), and negative valence/negative arousal (sedative effects). Summed subscores on the SEAS range between 0 and 40. Change scores can therefore range between -40 and 40 (post-beverage compared to pre-beverage feelings). Scores greater than 0 on any one subscale indicates feeling more effects of alcohol.
Change in Functional Coupling Between Regions of Interest During Viewing of Emotional Stimuli (Neural Responses While Viewing Emotional Stimuli Were Contrasted Against Neural Responses When Viewing Squares)
Time frame: up to 1 week
Neural responses to emotional stimuli during the alcohol and placebo sessions were modeled. Fisher transformed correlation coefficients between regions of interest while viewing emotional stimuli (compared to squares) were calculated for each beverage session and data extracted for posthoc analysis. Values represent change scores in correlation coefficients during each beverage session.

Results and safety

Results posted to the registry on 19 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BD Alcohol First, Then Placebo	16	15
TD Alcohol First, Then Placebo	15	13
BD Placebo First, Then Alcohol	14	13
TD Placebo First, Then Alcohol	15	14

Primary outcome: 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. Mean (Standard Error). Unit: score on a scale

Measure	BD Alcohol First, Then Placebo n = 15	TD Alcohol First, Then Placebo n = 13	BD Placebo First, Then Alcohol n = 13	TD Placebo First, Then Alcohol n = 13
SEAS positive valence/positive arousal: alcohol session	7.3 (1.2)	3.6 (1.0)	15.4 (2.3)	6.3 (1.3)
SEAS positive valence/positive arousal: placebo session	4.1 (1.1)	2.3 (0.98)	5.3 (1.8)	3.3 (1.1)
SEAS positive valence/negative arousal: alcohol session	-1.4 (1.6)	-5.3 (0.9)	7.1 (2.1)	0.9 (1.4)
SEAS positive valence/negative arousal: placebo session	1.7 (0.98)	-0.42 (0.47)	-2.3 (0.97)	-2.96 (4.7)

BD Alcohol First, Then Placebo vs TD Alcohol First, Then Placebo vs BD Placebo First, Then Alcohol vs TD Placebo First, Then Alcohol: p <0.05, Mixed Models Analysis

Population analysed: Excluded participants with placebo manipulation issues. One TD participant was excluded because they later revealed a past depressive episode.

Primary outcome: Change in Functional Coupling Between Regions of Interest During Viewing of Emotional Stimuli (Neural Responses While Viewing Emotional Stimuli Were Contrasted Against Neural Responses When Viewing Squares)

Time frame: up to 1 week. Mean (Standard Error). Unit: Change scores in correlation coefficient

Measure	BD Alcohol First, Then Placebo n = 11	TD Alcohol First, Then Placebo n = 12	BD Placebo First, Then Alcohol n = 12	TD Placebo First, Then Alcohol n = 13
Insula:sgACC functional connectivity: alcohol	-0.04 (0.02)	0.03 (0.02)	0.002 (0.02)	0.05 (0.03)
Insula:sgACC functional connectivity: placebo	0.001 (0.02)	-0.0003 (0.02)	0.05 (0.01)	-0.006 (0.02)
Left NAc:vmPFC functional connectivity: alcohol	-0.006 (0.03)	-0.05 (0.02)	0.01 (0.02)	-0.02 (0.03)
Left NAc:vmPFC functional connectivity: placebo	-0.06 (0.02)	-0.002 (0.02)	-0.014 (0.03)	0.003 (0.02)

BD Alcohol First, Then Placebo vs TD Alcohol First, Then Placebo vs BD Placebo First, Then Alcohol vs TD Placebo First, Then Alcohol: p <0.004, Mixed Models Analysis

Population analysed: Analysis was completed prior to study completion.

Adverse events

Time frame: Adverse event data was collected following enrollment and through completion of both beverage sessions.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BD Alcohol First	0 of 15 (0%)	0 of 15 (0%)	0 of 15
TD Alcohol First	0 of 13 (0%)	0 of 13 (0%)	0 of 13
BD Placebo First	0 of 13 (0%)	0 of 13 (0%)	0 of 13
TD Placebo First	0 of 13 (0%)	0 of 13 (0%)	0 of 13
BD Alcohol Second	0 of 13 (0%)	0 of 13 (0%)	0 of 13
TD Alcohol Second	0 of 13 (0%)	0 of 13 (0%)	0 of 13
BD Placebo Second	0 of 15 (0%)	0 of 15 (0%)	0 of 15
TD Placebo Second	0 of 13 (0%)	0 of 13 (0%)	0 of 13

Limitations and caveats (from the sponsor): Drinking was performed in a clinical space and lacks ecological validity (representing real world drinking environment). How individuals reported feeling may not generalize to how they feel when they consume alcohol regularly. Additionally, participants were the only one drinking. Individuals may respond differently when drinking in more social environments.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 37474761Kirsch DE, Kosted R, Le V, Almeida JRC, Fromme K, Strakowski SM, Lippard ETC. Ventral prefrontal network response to alcohol in young adults with bipolar disorder: a within-subject randomized placebo-controlled alcohol administration study. Neuropsychopharmacology. 2023 Dec;48(13):1910-1919. doi: 10.1038/s41386-023-01657-6. Epub 2023 Jul 20.
Results publication: PubMed 37353164Kosted R, Kirsch DE, Le V, Fromme K, Lippard ETC. Subjective response to alcohol: Interactive effects of early life stress, parental risk for mood and substance use disorders, and drinking context. Pharmacol Biochem Behav. 2023 Aug;229:173591. doi: 10.1016/j.pbb.2023.173591. Epub 2023 Jun 22.
Results publication: PubMed 36695842Lippard ETC, Kirsch DE, Kosted R, Le V, Almeida JRC, Fromme K, Strakowski SM. Subjective response to alcohol in young adults with bipolar disorder and recent alcohol use: a within-subject randomized placebo-controlled alcohol administration study. Psychopharmacology (Berl). 2023 Apr;240(4):739-753. doi: 10.1007/s00213-023-06315-9. Epub 2023 Jan 25.
Results publication: PubMed 36206822Kirsch DE, Le V, Kosted R, Fromme K, Lippard ETC. Neural underpinnings of expecting alcohol: Placebo alcohol administration alters nucleus accumbens resting state functional connectivity. Behav Brain Res. 2023 Feb 2;437:114148. doi: 10.1016/j.bbr.2022.114148. Epub 2022 Oct 4.
Individual participant dataSharing planned: Yes. After study completion and publication of finding, functional neuroimaging data and behavior data collected following alcohol and placebo conditions will be shared.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elizabeth Lippard, PhD principal investigator

University of Texas at Austin

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing alcohol beverage in people with Bipolar Disorder and Alcohol Drinking, run by University of Texas at Austin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04063384, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025; AzTrials last refreshed its copy on 3 Nov 2026.