Alcohol Response for Bipolar Disorder

(Long_BACS Trial)

Overseen By Research Coordinator

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Must not be taking: Psychotropics

Disqualifiers: Significant illness, Neurologic abnormality, IQ <85, others

Compensation: Varies

Number of Visits: 4

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore why alcohol use disorders (AUDs) are common in people with bipolar disorder and how alcohol affects them compared to those without the disorder. Researchers will study changes in brain activity and responses to stress and alcohol over two years. Participants will consume either alcohol or a placebo (a non-alcoholic drink that looks and tastes like alcohol) to observe differences in behavior and brain activity. Ideal candidates are young adults aged 21-26 who have bipolar disorder or are typically developing and have consumed several drinks on a single occasion in the past year. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research that could improve understanding and treatment of AUDs in bipolar disorder.

Will I have to stop taking my current medications?

The trial requires that participants with bipolar disorder must be stable on their medications for at least 4 weeks before joining. This means you should not stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that drinking alcohol can be risky for people with bipolar disorder because it often worsens mood symptoms. This study examines how alcohol affects people with bipolar disorder compared to those without it. The main concern is that alcohol might cause more severe symptoms or mood swings in people with bipolar disorder.

Previous studies have not identified specific safety issues with controlled alcohol use in research settings. This study involves administering controlled amounts of alcohol under medical supervision, which differs from regular drinking. This careful approach manages safety concerns and allows close monitoring of any side effects.

Overall, while alcohol can be harmful in everyday situations, this study provides a safe environment to better understand its effects. Researchers closely monitor participants to minimize risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how alcohol affects individuals with bipolar disorder, which is a novel approach. Unlike standard treatments that typically involve mood stabilizers like lithium or antipsychotics, this study examines the immediate changes in behavior and neural activity after alcohol consumption. This could provide insights into the short-term impacts of alcohol on mood and brain function in bipolar disorder, potentially opening new avenues for understanding and managing the condition.

What evidence suggests that this trial's treatments could be effective for bipolar disorder and alcohol use disorders?

Previous studies have shown that people with bipolar disorder and alcohol use disorder (AUD) experience better outcomes when they reduce alcohol consumption. One study found that individuals with both bipolar disorder and alcoholism often fare better over time compared to those with only alcoholism. This indicates that cutting back on alcohol can help people with both conditions feel and function better. Research also shows that attempting to stop drinking early often leads to better long-term results. These findings suggest that understanding the interaction between bipolar disorder and AUD can be key to improving quality of life for those with both conditions. In this trial, participants will receive either an alcohol or placebo beverage to examine changes in behavior and neural activity. ^{1 2 5 6 7}

Who Is on the Research Team?

Elizabeth Lippard, PhD

Principal Investigator

University of Texas at Austin

Are You a Good Fit for This Trial?

This study is for young adults aged 21-26, both with bipolar disorder and typical development. Participants must have had a certain level of alcohol use in the past year but not severe alcohol use disorders or other significant medical conditions. They should be stable on medications if any, and able to undergo MRI scans.

Inclusion Criteria

Participants must have consumed at least 4 (men) or 3 (women) drinks on a single occasion over the last year

Participants must be euthymic at the time of enrollment

I am between 21 and 26 years old.

Exclusion Criteria

I have a history of heart issues, high blood pressure, diabetes, or liver disease.

Full Scale intelligence quotient (IQ) <85

History of significant medical illness, particularly if possible changes in cerebral tissue

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline clinical, MRI, and placebo-controlled alcohol administration sessions

4 weeks

1 visit (in-person)

Longitudinal Follow-up

Participants are monitored for changes in subjective response to alcohol and neural trajectories over a two-year period

2 years

2 visits (in-person) at 1-year and 2-year follow-up

Psychosocial Stress Task

A subset of participants complete a psychosocial stress and neutral fMRI task followed by an alcohol session

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Alcohol vs. Placebo beverage conditions

Trial Overview The trial investigates how individuals with bipolar disorder respond to alcohol compared to a placebo beverage. It aims to understand biological risk factors for developing alcohol misuse by using neuroimaging techniques over two years.

How Is the Trial Designed?

Group I: Alcohol Active Control 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

placebo beverage condition

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Published Research Related to This Trial

A study of 30 patients with bipolar disorder revealed significant alcohol consumption, averaging 18.4 drinking days per month and nearly 10 drinks per day, indicating a high prevalence of alcohol use in this population.

The findings showed that patients with rapid cycling bipolar disorder consumed more alcohol per day compared to those with non-rapid cycling bipolar disorder, suggesting that different bipolar subtypes may have varying patterns of alcohol use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of alcohol consumption in bipolar patients comorbid for alcohol abuse or dependence. McKowen, JW., Frye, MA., Altshuler, LL., et al.[2007]

Unmedicated young males with a history of hypomanic experiences (bipolar phenotype participants) reported significantly lower subjective intoxication effects from alcohol compared to healthy controls, indicating a potential biomarker for alcohol use disorders (AUDs).

Despite their lower subjective responses, these participants had higher expectations of alcohol's positive effects, suggesting that diminished intoxication may contribute to increased alcohol misuse among those at risk for bipolar disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced subjective response to acute ethanol administration among young men with a broad bipolar phenotype. Yip, SW., Doherty, J., Wakeley, J., et al.[2022]

In a study of 137 outpatients with bipolar disorder over 52 weeks, neither moderate nor excessive alcohol use was found to negatively impact the course or outcome of their illness, contradicting previous research.

The study measured various clinical outcomes, including mood severity and overall functioning, and found no significant differences among patients based on their alcohol consumption levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of moderate and excessive alcohol use on the course and outcome of patients with bipolar disorders: a prospective cohort study. van Zaane, J., van den Brink, W., Draisma, S., et al.[2010]

About 23% of patients with bipolar disorder (BD) also have a lifetime diagnosis of alcohol use disorder (AUD), with significant differences in demographics and clinical characteristics between those with and without AUD.

Key factors associated with a lifetime AUD diagnosis in BD patients include male gender, rapid cycling, history of substance use disorders, PTSD, and younger age at onset of bipolar disorder, indicating that these factors can help identify patients at higher risk for AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and clinical correlates of alcohol use disorders among bipolar disorder patients: results from the Brazilian Bipolar Research Network. Nery, FG., Miranda-Scippa, A., Nery-Fernandes, F., et al.[2018]

Young adults with bipolar disorder reported a greater stimulating effect and enjoyment from alcohol compared to healthy young adults, indicating a heightened subjective response to alcohol that may increase their risk for alcohol use disorder (AUD).

Despite expecting to feel less relaxed when drinking, participants with bipolar disorder actually felt more mellow and relaxed during alcohol consumption, which was linked to higher recent alcohol use, suggesting a complex relationship between mood, alcohol response, and drinking behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subjective response to alcohol in young adults with bipolar disorder and recent alcohol use: a within-subject randomized placebo-controlled alcohol administration study. Lippard, ETC., Kirsch, DE., Kosted, R., et al.[2023]

In a study of 89 adults with bipolar disorder, 57.8% of those with bipolar I disorder were found to have substance or alcohol abuse dependence, indicating a high prevalence of comorbidity.

Bipolar I subjects showed higher rates of substance abuse compared to bipolar II subjects, with alcohol being the most commonly abused substance, although further research is needed to confirm these findings due to the small number of bipolar II participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifetime prevalence of substance or alcohol abuse and dependence among subjects with bipolar I and II disorders in a voluntary registry. Chengappa, KN., Levine, J., Gershon, S., et al.[2019]

In a study of 46 adolescents and young adults with bipolar disorder, reductions in risky alcohol use were linked to improvements in NMDA receptor function, as measured by changes in mismatch negativity (MMN) over an average follow-up of about 18 months.

Larger MMN amplitudes at baseline predicted higher alcohol use at follow-up, suggesting that monitoring MMN could help identify individuals at risk for alcohol misuse in bipolar disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The N-methyl-D-aspartate receptor as a neurobiological intersection between bipolar disorder and alcohol use: a longitudinal mismatch negativity study. Chitty, KM., Lagopoulos, J., Kaur, M., et al.[2018]

In a study of 284 bipolar disorder patients followed for 4 years, alcohol use disorders were found to be more prevalent in bipolar II patients (26.8%) compared to bipolar I patients (14.9%), highlighting a significant association between alcohol use and bipolar disorder severity.

The presence of alcohol use disorders significantly increased the risk of depressive relapse in bipolar I patients, with a hazard ratio of 2.7, indicating that addressing alcohol use is crucial for improving long-term outcomes in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and impact of comorbid alcohol use disorder in bipolar disorder: A prospective follow-up study. Simhandl, C., Radua, J., König, B., et al.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3730445/

Bipolar Disorder and Alcohol Use Disorder: A review - PMC IGT patients had significantly better substance use outcomes than did those who received GDC: IGT patients had approximately half as many days of substance use ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6683827/

Bipolar Disorder and Alcoholism - PMC O'Sullivan and colleagues (1988) found that alcoholics with bipolar disorder functioned better during a 2-year followup period than did primary alcoholics (i.e. ...

3. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2021.660432/full

Comorbid Bipolar and Alcohol Use Disorder—A ... A Brazilian study reports of at least one suicide attempt in 68% of BD patients with AUD compared to 35% in BD without AUD, with virtually no ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0165032725011875

Alcohol use across trials of psychological interventions for ... Across the 92 trials identified, 31 (33.7%) reported alcohol-related exclusion, and only 3 (3.3%) measured alcohol use at follow-up. The pooled effect sizes for ...

5. academic.oup.com academic.oup.com/alcalc/article/48/1/93/175634

Prognostic Factors of 2-year Outcomes of Patients with ... Early abstinence (at 6 months) predicted better abstinence overall at 2 years; and bipolar alcoholics had a better outcome in drinks per drinking day than ...

6. journalbipolardisorders.springeropen.com journalbipolardisorders.springeropen.com/articles/10.1186/s40345-025-00388-5

Exploring the temporal relationship between mood, alcohol Our findings indicate that mood influences alcohol- and nicotine use and vice versa in individuals with BD, although caution should be taken due ...

7. mayoclinic.org mayoclinic.org/diseases-conditions/bipolar-disorder/expert-answers/bipolar-disorder/faq-20057890

Bipolar disorder and alcoholism: Are they related? Bipolar disorder and alcohol use disorder, or other types of substance misuse, can be a dangerous mix. Each condition can make the symptoms of ...