PT150 Drug for Use in Alcohol Use Disorder
Recruiting now · Phase 1
Conditions studied: Alcohol Use Disorder
In brief
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.
Key facts
- Study ID
- NCT06712602
- Run by
- Pop Test Oncology LLC
- People needed
- 34
- Starts
- 2025-02-01
- Expected to finish
- 2028-07-31
- Last updated by the study team
- 2025-05-22
Who can join
Age: 21 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- University of Kentucky — Lexington, Kentucky, United States (enrolling)
Full record on ClinicalTrials.gov
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