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Study to Evaluate AD04 in Adults With Alcohol Use Disorder (AUD) and Selected Serotonin Transporter Polymorphisms

NCT04101227 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2024-04-17

No results posted yet for this study

Summary

Randomized, multi-center, double-blind, parallel-group, placebo-controlled study. Eligible subjects will be randomized to receive either 0.33 mg AD04 or placebo orally twice-daily for 24 weeks in conjunction with brief psychological counseling. Randomization will be stratified by:

1. Level of alcohol consumption prior to enrollment in the study (heavy drinkers averaging \<10 drinks per day of drinking or very heavy drinkers averaging ≥10 drinks per day of drinking), and
2. Gender (male or female).

Conditions

Interventions

DRUG

AD04 (ondansetron)

AD04 (ondansetron) 0.33 mg, orally (p.o.) twice a day (BID)

DRUG

Matching placebo

Matching placebo to AD04 (ondansetron), orally (p.o.) twice a day (BID)

DEVICE

Companion Diagnostic for Genetic Testing

Companion Diagnostic for Genetic Testing

BEHAVIORAL

Brief Psychological Counseling

Brief Psychological Counseling

Sponsors & Collaborators

  • Adial Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Professor, Dr Hannu Alho · National Institute for Health and Welfare Research Center Biomedicum

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2022-02-18
Completion
2022-03-18

Countries

  • Bulgaria
  • Croatia
  • Estonia
  • Finland
  • Latvia
  • Poland
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04101227 on ClinicalTrials.gov