NCT04101227 - Study to Evaluate AD04 in Adults With Alcohol Use Disorder (AUD) and Selected Serotonin Transporter Polymorphisms | Biotech Hunter

Enrollment

302

Participants

Timeline

Start Date

February 1, 2020

Primary Completion Date

February 18, 2022

Study Completion Date

March 18, 2022

Conditions

Alcohol Use Disorder

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

BEHAVIORAL

Brief Psychological Counseling

Trial Locations (25)

Unknown

Mental Health Centre Prof. Dr. Ivan Temkov Burgas EOOD Department for treatment of Emergency Psychiatric conditions, Burgas

State Psychiatric Hospital, Kardzhali

UMHAT Dr. Georgi Stranski Second Psychiatric Clinic, Pleven

Ambulatory for Group Practice for Specialized Psychiatric Help - Philipopolis OOD, Plovdiv

Medical Center Intermedica OOD, Sofia

State Psychiatric Hospital for Treatment of drug addiction and alcoholism, Sofia

Diagnostic-Consultative Center Mladost-М Varna, Varna

Clinical Hospital Center Split, Split

Polyclinic Neuron, Zagreb

University Psychiatric Hospital Vrapče Klinika za psihijatriju Vrapče, Zagreb

West Tallinn Central Hospital, Haabersti Health Center, Tallinn

Savon psykiatripalvelu, Kuopio

Mentalcare, Oulu

Satakunnan Psykiatripalvelu Oy, Pori

Satakunnan Psykiatripalvelu Oy, Tampere

Addiktum Oy, Turku

Liepaja Regional Hospital Addictive disorder department, Liepāja

M&M Centrs, Riga

Strenci Psychoneurological Hospital, Strenči

Centrum Medyczne Luxmed Sp. z. o. o., Lublin

NZOZ Prywatna Klinika Psychiatryczna, Tuszyn

Clinical Research Group Sp. z.o.o, Warsaw

Ladulaas Kliniska Studier, Borås

ClinSmart Sweden AB, Uppsala

00120

Addiktum klinikka Helsinki, Helsinki