Study of Sunobinop on Alcohol Consumption in Alcohol Use Disorder

NCT ID: NCT06545916

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-14

Study Completion Date

2026-03-31

Brief Summary

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The purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol consumption in subjects with alcohol use disorder.

Detailed Description

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Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Sunobinop

Group Type EXPERIMENTAL

Sunobinop

Intervention Type DRUG

1 tablet taken orally at bedtime

Placebo to match sunobinop

Group Type PLACEBO_COMPARATOR

Placebo to match sunobinop

Intervention Type DRUG

1 tablet taken orally at bedtime

Interventions

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Sunobinop

1 tablet taken orally at bedtime

Intervention Type DRUG

Placebo to match sunobinop

1 tablet taken orally at bedtime

Intervention Type DRUG

Other Intervention Names

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V117957

Eligibility Criteria

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Inclusion Criteria

* Male and female age ≥18 years.
* Diagnosis of moderate or severe alcohol use disorder.
* Currently seeking treatment for alcohol use disorder.
* Has 4 or more heavy drinking days (HDD) in each of the 4 weeks prior to baseline visit.

Exclusion Criteria

* Subjects that meet current DSM-5 criteria for moderate or severe substance use disorder other than alcohol and nicotine.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Purdue Pharma LP

INDUSTRY

Sponsor Role collaborator

Imbrium Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Belmont Medical Office

Brooklyn, New York, United States

Site Status RECRUITING

Ohio Clinical Trials

Columbus, Ohio, United States

Site Status RECRUITING

Inquest Clinical Research

Baytown, Texas, United States

Site Status RECRUITING

Cebis Usa, Llc

Houston, Texas, United States

Site Status RECRUITING

Bio Terra Med SRL

Bucharest, , Romania

Site Status RECRUITING

Spitalul Universitar De Urgenta Militar Central "Dr. Carol Davila"

Bucharest, , Romania

Site Status RECRUITING

Cabinet Medical Individual Dr. Andreea Popa

Bucharest, , Romania

Site Status RECRUITING

Countries

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United States Romania

Central Contacts

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Medical Information

Role: CONTACT

1-888-827-0622

Facility Contacts

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Central Contact

Role: primary

Central Contact

Role: primary

Central Contact

Role: primary

Central Contact

Role: primary

Central Contact

Role: primary

Central Contact

Role: primary

Central Contact

Role: primary

Other Identifiers

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2024-517105-85-00

Identifier Type: CTIS

Identifier Source: secondary_id

SUN2003A

Identifier Type: -

Identifier Source: org_study_id

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