What side effects are associated with this type of intervention?

Common treatments for Alcohol Use Disorder (AUD) include medications like naltrexone, acamprosate, and disulfiram. For treatments similar to Brexpiprazole, which modulate serotonin and dopamine activity, side effects can include weight gain, metabolic changes, somnolence, and extrapyramidal symptoms such as tremors or rigidity. These side effects are important to monitor, especially in patients with pre-existing conditions that may be exacerbated by these medications.

What prior FDA approvals exist?

Currently, few medications are FDA-approved for the treatment of Alcohol Use Disorder (AUD), and those available generally have modest effects on reducing drinking. These include naltrexone, acamprosate, and disulfiram. Brexpiprazole, a serotonin/dopamine activity modulator (SDAM), is being studied as a potential novel treatment for AUD. Previous research has shown that genetic variations can influence the effectiveness of similar SDAMs, such as aripiprazole, in treating AUD. If successful, brexpiprazole could represent a new pharmacogenetic approach to managing AUD.

What other types of research exist?

Promising novel alternatives to Brexpiprazole for treating Alcohol Use Disorder in 2024 include Naltrexone, Acamprosate, and Gabapentin. These medications have shown efficacy in reducing alcohol consumption and cravings. Additionally, emerging treatments such as Varenicline and Topiramate are being studied for their potential benefits in AUD management.

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Serotonin/Dopamine Activity Modulator

Brexpiprazole for Alcoholism

Phase 2

Recruiting

Led By Joseph P Schacht, PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 21-65

Currently not engaged in, and does not want treatment for, AUD

Must not have

Current or past hepatocellular disease, as indicated by verbal report or elevations of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of the normal range at screening

History of head injury with loss of consciousness for more than 2 minutes, neurological illness, or history of neurosurgical procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days - change between baseline and day 14 scan.

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial tests whether brexpiprazole can help reduce alcohol consumption in people with Alcohol Use Disorder who are not seeking treatment. The medication works by balancing brain chemicals related to mood and behavior. Researchers will also see if genetic differences affect how well the medication works. Brexpiprazole is a newer medication related to aripiprazole, which has shown potential in reducing alcohol use by stabilizing dopamine and serotonin systems.

Who is the study for?

This trial is for adults aged 21-65 with Alcohol Use Disorder who aren't seeking treatment and don't take medication for AUD. Participants must be physically healthy, live near the study site, have a negative drug screen, and not suffer from severe mental health disorders or significant medical illnesses.

What is being tested?

The trial tests Brexpiprazole's effectiveness in reducing alcohol consumption compared to a placebo. It also examines if genetic differences (DAT1 genotype) affect its efficacy. The study includes natural condition assessments and lab-based drinking tasks, supplemented by brain imaging studies.

What are the potential side effects?

While specific side effects of Brexpiprazole are not listed here, similar medications can cause drowsiness, headache, digestive issues, restlessness, weight gain and may increase the risk of diabetes or cholesterol problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 65 years old.

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I am not seeking treatment for alcohol use disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have liver disease or my liver tests are higher than normal.

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I have had a head injury, lost consciousness for over 2 minutes, or had brain surgery.

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I am not currently having thoughts of harming myself or others.

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I have difficulty making decisions due to my health condition.

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I am currently taking medication for mental health issues.

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I have no major health issues like heart, kidney, stomach, or hormone problems.

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I am not pregnant, nursing, and I use reliable contraception.

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I have been diagnosed with a mental health disorder like depression, anxiety, or OCD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days - change between baseline and day 14 scan.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days - change between baseline and day 14 scan.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days - change between baseline and day 14 scan. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in alcohol cue-elicited brain activation (fMRI)

Number of drinks consumed in bar lab

Drunk driving

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: BREX 4mgActive Control1 Intervention

The BREX 4mg group will start at the same dose as the BREX 2mg group and titrate up at the same rate, so the BREX 4mg Arm will take .5 mg of brexpiprazole on day 1-2, 1 mg on day 3-4, 2mg on day 5-6, and 4mg on day 7 to reach its final 4mg dose for days 7-14. To ensure pill equivalence between groups, tablets will be packaged in the same capsule; thus, each participant will take one capsule per day. Participants will be instructed to ingest the medication orally each morning.

Group II: BREX 2mgActive Control1 Intervention

The BREX 2mg group will start at the same dose at the BREX 4mg group and titrate up at the same rate, so the BREX 2mg Arm will take .5 mg of brexpiprazole on day 1-2, 1 mg on day 3-4, and 2mg on day 5, to reach its final 2mg dose for day 5-14. To ensure pill equivalence between groups, tablets will be packaged in the same capsule; thus, each participant will take one capsule per day. Participants will be instructed to ingest the medication orally each morning.

Group III: PlaceboPlacebo Group1 Intervention

Participants in this Arm will take a medically inert placebo. To ensure pill equivalence between groups, tablets will be packaged in the same capsule; thus, each participant will take one capsule per day. Participants will be instructed to ingest the capsule orally each morning.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Brexpiprazole, a serotonin/dopamine activity modulator (SDAM), works by balancing the activity of serotonin and dopamine receptors in the brain, which are crucial in regulating mood, reward, and impulse control. This modulation can help reduce the craving and consumption of alcohol by stabilizing mood and reducing the rewarding effects of alcohol. Other common treatments for Alcoholism include naltrexone, which blocks opioid receptors to reduce the pleasurable effects of alcohol, and acamprosate, which stabilizes chemical signaling in the brain to reduce withdrawal symptoms. Understanding these mechanisms is important for patients as it helps tailor treatments to their specific neurochemical imbalances, potentially improving outcomes.

Effects of fluvoxamine on a multiple schedule of ethanol- and food-maintained behavior in two rat strains.