NCT06545916

Brief Summary

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

Trial Health

58
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2024

Geographic Reach
2 countries

7 active sites

Status
active not recruiting

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
2 months until next milestone

Study Start

First participant enrolled

October 14, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

August 6, 2024

Last Update Submit

March 3, 2026

Conditions

Alcohol Use Disorder

Keywords

Alcohol consumptionModerate to severe alcohol use disorder

Outcome Measures

Primary Outcomes (1)

  • Percent heavy drinking days (HDD)

    Day 57

Secondary Outcomes (2)

  • Number of standard unit drinks

    Day 57

  • Percent of drinking days (PDD)

    Day 57

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 (7)

Belmont Medical Office

Brooklyn, New York, 11212, United States

Location

Ohio Clinical Trials

Columbus, Ohio, 43212, United States

Location

Inquest Clinical Research

Baytown, Texas, 77521, United States

Location

Cebis Usa, Llc

Houston, Texas, 77074, United States

Location

Bio Terra Med SRL

Bucharest, 010701, Romania

Location

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

Bucharest, 010825, Romania

Location

Cabinet Medical Individual Dr. Andreea Popa

Bucharest, 050802, Romania

Location

MeSH Terms

Conditions

AlcoholismAlcohol Drinking

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDrinking BehaviorBehavior

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

October 14, 2024

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

RO(3)US(4)