NCT06545929

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

January 28, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

August 6, 2024

Last Update Submit

July 22, 2025

Conditions

Alcohol Use Disorder

Keywords

Alcohol cravingModerate to severe alcohol use disorder

Outcome Measures

Primary Outcomes (1)

  • Alcohol Urge Questionnaire (AUQ)

    The questionnaire consists of 8 items; each with 7-item scale in which 1= "strongly disagree" and 7 = "strongly agree".

    Day 14

Secondary Outcomes (1)

  • Desire for Alcohol Visual Analog Scale (DFA-VAS)

    Day 14

Study Arms (2)

Sunobinop

EXPERIMENTAL
Drug: Sunobinop

Placebo to match sunobinop

PLACEBO COMPARATOR
Drug: Placebo to match sunobinop

Interventions

SunobinopDRUG

1 tablet taken orally at bedtime

Also known as: V117957
Sunobinop
Placebo to match sunobinopDRUG

1 tablet taken orally at bedtime

Placebo to match sunobinop

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio Clinical Trials

Columbus, Ohio, 43212, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2024

First Posted

August 9, 2024

Study Start

January 28, 2025

Primary Completion

July 14, 2025

Study Completion

July 14, 2025

Last Updated

July 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)