PT150 Drug for Use in Alcohol Use Disorder

NCT06712602 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 90580R01AA030774
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Keywords

Alcohol; Alcohol Use Disorder; Alcoholism

Outcome Measures

Primary Outcomes (5)

• Change in salivary cortisol (alcohol)

  Salivatory samples will be collected before and periodically after the alcohol challenge procedure for 120 minutes using cotton swab salivettes.

  Baseline, week 1, week 2, week 3, and follow up (up to 34 days)

• Change in salivary cortisol (stress induction)

  Salivatory samples will be collected before and periodically after the stress induction procedure for 120 minutes using cotton swab salivettes.

  Baseline, week 1, week 2, week 3, and follow up visit (up to 34 days)

• Change in Alcohol Demand (stress induction)

  A drug purchasing task will be used to determine how many hypothetical doses of their preferred alcohol beverage participants would purchase across varying prices.

  Baseline, and sessions 1 - 3 (up to 30 days)

• Change in Alcohol Demand (alcohol)

  A drug purchasing task will be used to determine how many hypothetical doses of the alcoholic beverage given during the session participants would purchase across varying prices.

  Baseline, and sessions 1 - 3 (up to 30 days)

• Change in Mood (Alcohol)

  The short form of the Profile of Mood States. The POMS-SF uses five-point scales (Not at All to Extremely) to measure six aspects of mood (Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment).

  Baseline, and sessions 1 - 3 (up to 30 days)

Secondary Outcomes (6)

• Change in Heart Rate (Stress)

  Baseline, sessions 1 - 3, and follow up visit (up to 34 days)

• Change in Heart Rate (Alcohol)

  Baseline, sessions 1 - 3, and follow up visit (up to 34 days)

• Change in blood pressure (stress)

  Baseline, sessions 1 - 3, and follow up visit (up to 34 days)

• Change in blood pressure (alcohol)

  Baseline, sessions 1 - 3, and follow up visit (up to 34 days)

• Change in motor coordination

  Baseline, and sessions 1 - 3 (up to 30 days)]

Study Arms (2)

PT150 with alcohol consumption then stress

EXPERIMENTAL

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.

Drug: alcohol; Behavioral: Stress-Induction; Drug: PT150

PT150 with stress then alcohol consumption

EXPERIMENTAL

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.

Drug: alcohol; Behavioral: Stress-Induction; Drug: PT150

Interventions

alcohol DRUG

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.

PT150 with alcohol consumption then stress; PT150 with stress then alcohol consumption

Stress-Induction BEHAVIORAL

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 with alcohol consumption then stress; PT150 with stress then alcohol consumption

PT150 DRUG

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.

PT150 with alcohol consumption then stress; PT150 with stress then alcohol consumption

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pop Test Oncology LLC: lead
• University of Kentucky: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol; (11R,13S,17S)-11-(1,3-benzodioxol-5-yl)-17-hydroxy-13-methyl-17-prop-1-ynyl-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta(a)phenanthren-3-one

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Mark Fillmore, PhD

  Uiversity of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Fillmore, PhD

CONTACT

859-257-4728; Fillmore@uky.edu

Kelsey Padgett, PhD

CONTACT

859-257-5794; Ktpa223@uky.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 2, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)