Recruiting
Phase 1

PT150

Sponsor:

Pop Test Oncology LLC

Code:

NCT06712602

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Not accepted

Interventions

alcohol

Stress-Induction

PT150

Study Details

Brief 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

Alcohol Use Disorder

Study ID

NCT06712602

Start date

Feb 1, 2025

Status verified date

May, 2025

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Not seeking treatment at the time of the study

English-speaking

Between the ages of 21 and 55 years (individuals under 21 are excluded based on the recommendations of NIAAA that alcohol should not be administered to individuals under the legal drinking age)

Abstinent from alcohol no more than 3 days per week on average

Physically and psychiatrically healthy other than the diagnoses for AUD or tobacco use disorder

ECG, read by cardiologist, within normal limits

Body mass index of 19 - 35

Using an effective form of birth control (e.g., birth control pills, surgical sterilization, condoms, IUD, cervical cap with a spermicide or abstinence) if female

Able to abstain from ALC for 12 hours prior to sessions

No contraindications to ALC or PT150

Exclusion Criteria:

Meet diagnostic criteria for SUDs, save nicotine, other than AUD that in the opinion of a study physician would require medical intervention (e.g., opioid use disorder) or compromise the well-being of the participant

Have abnormal blood chemistry, complete blood count or urinalysis values deemed clinically significant

Have a history of serious physical disease or current physical disease (e.g., impaired cardiovascular functioning, histories of seizure, head trauma or CNS tumors)

Have a current or past history of psychiatric disorder that would interfere with participation (e.g., psychotic \[schizophrenia, schizoaffective\]), bipolar, major depressive disorder)

Have had suicidal ideations in the past 90 days

Pregnant or nursing

Are unwilling/unable to comply with study procedures

Participants scoring >6 on the Clinical Institute Withdrawal Assessment for Alcohol Revised (CIWA-Ar); the CIWA-Ar will be administered prior to each experimental session participants who score >6 will be excluded further participation.

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PT150 with alcohol consumption then stress

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.

experimental: PT150 with stress then alcohol consumption

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.

Interventions

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.

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.

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.

Primary outcome measure

  • Change in salivary cortisol (alcohol) [ Time Frame: Baseline, week 1, week 2, week 3, and follow up (up to 34 days) ]
  • Change in salivary cortisol (stress induction) [ Time Frame: Baseline, week 1, week 2, week 3, and follow up visit (up to 34 days) ]
  • Change in Alcohol Demand (stress induction) [ Time Frame: Baseline, and sessions 1 - 3 (up to 30 days) ]
  • Change in Alcohol Demand (alcohol) [ Time Frame: Baseline, and sessions 1 - 3 (up to 30 days) ]
  • Change in Mood (Alcohol) [ Time Frame: Baseline, and sessions 1 - 3 (up to 30 days) ]

Central Contacts and Locations

Central contacts

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40506

Contacts

Principal Investigator:

Mark Fillmore, PhD

More Information

Sponsor

Pop Test Oncology LLC

Last update posted

May 22, 2025

Last verified

May, 2025

Keywords

  • Alcohol
  • Alcohol Use Disorder
  • Alcoholism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pop Test Oncology LLC on 2025-05-22.