PT150 Drug for Use in Alcohol Use Disorder

PHASE1RecruitingINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

February 1, 2025

Primary Completion Date

July 31, 2028

Study Completion Date

July 31, 2028

Conditions
Alcohol Use Disorder
Interventions
DRUG

alcohol

During the alcohol administration session participants will receive a single administration of alcohol (0.5 g/kg) mixed with lemon lime soda. Participants will consume the drink within 5 min.

BEHAVIORAL

Stress-Induction

The stress-induction procedure is the Cold Pressure Test \[CPT\]) stressor. The bilateral foot CPT requires participants to submerge both feet in ice-cold water (24°C) for 3 minutes.

DRUG

PT150

Participants will ingest PT150 (0, 225, 450 mg) twice daily (e.g., 0800, 2000h) for 5 five days prior to the conduct of the experimental sessions. The sequence of PT150 doses will be quasi-random such that participants will be maintained on the lower dose of PT150 (i.e., 225 mg twice/day) before the higher dose.

Trial Locations (1)

40506

RECRUITING

University of Kentucky, Lexington

All Listed Sponsors
collaborator

University of Kentucky

OTHER

collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

lead

Pop Test Oncology LLC

INDUSTRY