NCT06712602 PT150 Drug for Use in Alcohol Use Disorder
| NCT ID | NCT06712602 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Pop Test Oncology LLC |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 34 participants in total. It began in 2025-02-01 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Mark Fillmore, PhD
PRINCIPAL INVESTIGATOR
Uiversity of Kentucky
Frequently Asked Questions
Who can join the NCT06712602 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 55 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06712602 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06712602 currently recruiting?
Yes, NCT06712602 is actively recruiting participants. Contact the research team at Fillmore@uky.edu for enrollment information.
Where is the NCT06712602 trial being conducted?
This trial is being conducted at Lexington, United States.
Who is sponsoring the NCT06712602 clinical trial?
NCT06712602 is sponsored by Pop Test Oncology LLC. The principal investigator is Mark Fillmore, PhD at Uiversity of Kentucky. The trial plans to enroll 34 participants.