PT150 for Alcoholism

Overseen By Kelsey Padgett, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Pop Test Oncology LLC

Disqualifiers: Opioid use disorder, Schizophrenia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

34 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to understand any specific requirements.

What is the purpose of this trial?

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.

Research Team

Mark Fillmore, PhD

Principal Investigator

Uiversity of Kentucky

Eligibility Criteria

This trial is for English-speaking adults aged 21-55 with moderate to severe Alcohol Use Disorder (AUD) who aren't seeking treatment and can abstain from alcohol before sessions. They should be generally healthy, have a normal heart reading, not use drugs other than tobacco, and women must use birth control. People with serious diseases or significant mental health issues cannot join.

Inclusion Criteria

English-speaking

ECG, read by cardiologist, within normal limits

Meet diagnostic criteria for AUD (moderate or severe) per the Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM-5)

Exclusion Criteria

I have a serious or current physical illness.

Are unwilling/unable to comply with study procedures

Participants scoring >6 on the Clinical Institute Withdrawal Assessment for Alcohol Revised (CIWA-Ar)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Maintenance

Participants are maintained on a randomized dose of PT150 for at least five days before experimental sessions

1 week

Alcohol Administration Session

Participants receive a single administration of alcohol and are monitored for behavioral and physiological effects

1 day

1 visit (in-person)

Stress Induction Session

Participants undergo a stress-induction procedure using the Cold Pressure Test and are monitored for behavioral and neuroendocrinological responses

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

Treatment Details

Interventions

• PT150

Trial Overview The study tests if PT150 can lessen stress and alcohol's effects in those with AUD. Participants will undergo stress-induction procedures while their reactions to alcohol are observed. The aim is to see if PT150 helps manage the behavioral and physical impacts of stress related to alcohol consumption.

Participant Groups

Group I: PT150 with stress then alcohol consumption Experimental Treatment 3 Interventions

Following at least five days of maintenance on a randomized dose of PT150, participants will complete an experimental session involving stress induction. No less than 24 hours later, participants will then complete an experimental alcohol administration session.

Group II: PT150 with alcohol consumption then stress Experimental Treatment 3 Interventions

Following at least five days of maintenance on a randomized dose of PT150, participants will complete an experimental alcohol administration session. No less than 24 hours later, participants will then complete an experimental stress induction session.

Who Is Running the Clinical Trial?

Pop Test Oncology LLC

Lead Sponsor

Trials

3

Recruited

50+

University of Kentucky

Collaborator

Trials

198

Recruited

224,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+