PT150 drug for treating alcohol use disorder
Selective Glucocorticoid Receptor Antagonism in Alcohol Use Disorder: A Human Laboratory Study
This study is testing if the drug PT150 can help people with alcohol use disorder feel less stressed and reduce their alcohol cravings.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 21 Years to 55 Years |
| Sex | All |
| Sponsor | Pop Test Oncology LLC Industry-sponsored |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT06712602 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of PT150 in reducing the behavioral and physical effects of stress and alcohol use in individuals diagnosed with alcohol use disorder (AUD). Participants will undergo a stress-induction procedure using the Cold Pressure Test (CPT) while their behavioral and neuroendocrinological responses are monitored. The study employs computerized data collection to enhance accuracy and efficiency in data management. Participants will be seated comfortably during the sessions, which will include assessments of alcohol demand, craving, mood, and salivary cortisol levels.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 21 to 55 with moderate to severe alcohol use disorder who are not currently seeking treatment.
Not a fit: Patients with other substance use disorders or those who are seeking treatment for alcohol use disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for individuals struggling with alcohol use disorder.
How similar studies have performed: While this approach is novel, previous studies have shown promise in using stress-induction techniques to assess behavioral responses in alcohol use disorder.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lexington, Kentucky
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Mark Fillmore, PhD — Uiversity of Kentucky
- Study coordinator: Mark Fillmore, PhD
- Email: Fillmore@uky.edu
- Phone: 859-257-4728
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.