Study of Sunobinop on Craving in Alcohol Use Disorder

NCT ID: NCT06545929

Last Updated: 2025-07-23

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-28

Study Completion Date

2025-07-14

Brief Summary

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The purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol craving in subjects with moderate to severe alcohol use disorder and these subjects are seeking treatment.

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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Ohio Clinical Trials

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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SUN2003B

Identifier Type: -

Identifier Source: org_study_id

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