Study of Sunobinop on Craving in Alcohol Use Disorder

A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Evaluate Impact of Sunobinop (V117957) on Alcohol Craving in Subjects Diagnosed With Moderate to Severe Alcohol Use Disorder and Seeking Treatment

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06545929

Enrollment

Registered

2024-08-09

Start date

2025-01-28

Completion date

2025-07-14

Last updated

2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder

Keywords

Alcohol craving, Moderate to severe alcohol use disorder

Brief summary

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.

Interventions

DRUGSunobinop

1 tablet taken orally at bedtime

DRUGPlacebo to match sunobinop

1 tablet taken orally at bedtime

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria include: * 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. Key

Exclusion criteria

include: * Subjects that meet current DSM-5 criteria for moderate or severe substance use disorder other than alcohol and nicotine. Other protocol-specific inclusion and

Design outcomes

Primary

Measure	Time frame	Description
Alcohol Urge Questionnaire (AUQ)	Day 14	The questionnaire consists of 8 items; each with 7-item scale in which 1= "strongly disagree" and 7 = "strongly agree".

Secondary

Measure	Time frame	Description
Desire for Alcohol Visual Analog Scale (DFA-VAS)	Day 14	The scale consists of 1 item with 10-point scale in which 0 = "not at all" and 10 = "extremely high"

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026