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PT150 Drug for Use in Alcohol Use Disorder

NCT06712602 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-05-22

No results posted yet for this study

Summary

The goal of this study is to learn if PT150 can reduce the behavioral and physical effects of stress, alcohol, and alcohol use in people with alcohol use disorder.

Conditions

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.

Sponsors & Collaborators

  • University of Kentucky

    collaborator OTHER

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Pop Test Oncology LLC

    lead INDUSTRY

Principal Investigators

  • Mark Fillmore, PhD · Uiversity of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2028-07-31
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States

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 NCT06712602 on ClinicalTrials.gov