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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial will test whether the medication brexpiprazole (BREX) can help reduce drinking in people with Alcohol Use Disorder (AUD), and whether this effect is influenced by genetic variation in the gene encoding the dopamine transporter (DAT1).

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in alcohol cue-elicited brain activation (fMRI)

Number of drinks consumed in bar lab

Drunk driving

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,734 Previous Clinical Trials

2,148,633 Total Patients Enrolled

12 Trials studying Alcoholism

1,466 Patients Enrolled for Alcoholism

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

800 Previous Clinical Trials

1,362,747 Total Patients Enrolled

423 Trials studying Alcoholism

985,458 Patients Enrolled for Alcoholism

Joseph P Schacht, PhDPrincipal InvestigatorUniversity of Colorado, Denver

3 Previous Clinical Trials

197 Total Patients Enrolled

3 Trials studying Alcoholism

197 Patients Enrolled for Alcoholism

Media Library

Brexpiprazole (Serotonin/Dopamine Activity Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT04066192 — Phase 2

Alcoholism Research Study Groups: BREX 4mg, BREX 2mg, Placebo

Alcoholism Clinical Trial 2023: Brexpiprazole Highlights & Side Effects. Trial Name: NCT04066192 — Phase 2

Brexpiprazole (Serotonin/Dopamine Activity Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04066192 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Federal Drug Administration authorized BREX 2mg for use?

"As this is a Phase 2 clinical trial, the safety of BREX 2mg was rated at an intermediate level of two. This rating reflects the presence of limited data regarding its safety and absence of evidence attesting to efficacy."

Answered by AI

Is this research open to seniors aged sixty and above?

"This clinical trial's inclusion criteria only allows patients aged 21 to 65 to enroll. Participants younger than 18 will be able to partake in 35 other studies, while those older than 65 can join 255 separate trials."

Answered by AI

Is this a groundbreaking research initiative?

"Since 2017, BREX 2mg has been subject to extensive research. H. Lundbeck A/S sponsored the initial clinical trial in 2017 which involved 315 participants and led to Phase 3 drug approval for BREX 2mg. Currently 9 studies are being conducted around 14 cities across 3 countries related to this medication's efficacy."

Answered by AI

Who is eligible to apply for enrollment in this clinical trial?

"This trial is enrolling 250 eligible participants, aged 21 to 65, who have an active alcohol drinking habit. Some additional requirements include a lack of current AUD treatment, no medications taken for the same purpose, physical health with no major medical conditions and passing all drug tests prior to taking part in the study. Further inclusion criteria can be found by contacting local clinical sites."

Answered by AI

How many participants have signed up to be part of this clinical experiment?

"That is correct. Clinicaltrials.gov attests that this trial, which was initially posted on October 30th 2020 and revised most recently on August 12th 2022, seeks to enlist 250 participants from a single location."

Answered by AI

Are there any available spots for enrolment in this clinical trial?

"Affirmative. Data on clinicaltrials.gov reveals that this investigation is currently recruiting patients, having been initially posted in October 2020 and last modified in August 2022. The trial requires 250 people to be enrolled at a single site."

Answered by AI

Recent research and studies

NeuropsychopharmacologyJournal

Dopaminergic Genetic Variation Influences Aripiprazole Effects on Alcohol Self-administration and the Neural Response to Alcohol Cues in a Randomized Trial

Schacht, Joseph P, Konstantin E Voronin, Patrick K Randall, and Raymond F Anton. 2017. “Dopaminergic Genetic Variation Influences Aripiprazole Effects on Alcohol Self-administration and the Neural Response to Alcohol Cues in a Randomized Trial”. Neuropsychopharmacology. Springer Science and Business Media LLC. doi:10.1038/npp.2017.298.

clinicaltrials.govStudy

Brexpiprazole in Alcohol Use Disorder

2020. "Brexpiprazole in Alcohol Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04066192.

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