Clinical Trial to Evaluate the Safety of PT150 (Formerly ORG34517) When it is Taken Concurrently With Alcohol

PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

September 1, 2018

Primary Completion Date

July 15, 2019

Study Completion Date

July 15, 2019

Conditions
Alcohol DependenceAlcohol Interaction
Interventions
DRUG

PT150

Intervention 1 includes PT150 with alcohol consumption

OTHER

Beverage

Alcohol beverage will be prepared by an in-house pharmacist at the MEDVAMC in a volume of 450 ml for a 70 kg individual and adjusted for body weight by varying the volume. Alcohol will be administered in a concentration of 16% alcohol (Everclear, St. Louis, MO) by volume in grape Kool-Aid (Kraft Foods, Northfield, IL). Placebo will be prepared in the same manner but contain 1% alcohol to mask taste.

Trial Locations (1)

77030

Michael E. DeBakey Veterans Affairs Medical Center, Houston

All Listed Sponsors
collaborator

Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

OTHER

collaborator

Congressionally Directed Medical Research Programs

FED

collaborator

Michael E. DeBakey VA Medical Center

FED

collaborator

Baylor College of Medicine

OTHER

collaborator

University of California, San Diego

OTHER

lead

Pop Test Oncology LLC

INDUSTRY

NCT03548714 - Clinical Trial to Evaluate the Safety of PT150 (Formerly ORG34517) When it is Taken Concurrently With Alcohol | Biotech Hunter | Biotech Hunter