PT150 Drug for Use in Alcohol Use Disorder
Selective Glucocorticoid Receptor Antagonism in Alcohol Use Disorder: A Human Laboratory Study
Pop Test Oncology LLC
34 participants
Feb 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria11
- 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 Criteria8
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06712602