PT150 drug for treating alcohol use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Emotional Reactivity in Severe Alcohol Use Disorder and Depression Using Eye-Tracking and Physiological Measures

  This study tests how people with severe alcohol use disorder, major depressive disorder, both conditions, or neither, recognize and react to emotions using eye-tracking and physiological data.

  Recruiting Université Catholique de Louvain · Brussels, Belgium · NCT07925281

• Thiamine to reduce brain injury in adults with alcohol use disorder

  This trial tests whether thiamine can help protect the brain in adults with moderate to severe alcohol use disorder who drink daily.

  Recruiting Phase 2 Institut National de la Santé Et de la Recherche Médicale, France · Paris, Île-de-France Region · NCT07844720

• Digital Recovery Support for Black adults with Alcohol Use Disorder in Detroit

  This study tests whether a smartphone-based digital recovery program helps Black or African American adults in Detroit maintain their recovery from alcohol use disorder.

  Recruiting Brandeis University · Detroit, Michigan · NCT07724275

• Path180: a computer-based skills program to help teens reduce alcohol use

  This 8-week trial tests Path180, a computer-based skills training, added to usual care for teens 13–19 with alcohol use disorder to see if it improves daily-life coping skills and outcomes.

  Recruiting Brown University · Providence, Rhode Island · NCT07713251

• Effects of comorbidity on people with severe mental illness

  This study tests how having both alcohol/substance use and a severe mental illness affects hospitalizations, medications, and social participation among adults followed at a mental health center.

  Recruiting Abant Izzet Baysal University · Bolu, Bolu · NCT07692984

• Psilocybin in Alcohol Use Disorder with Depression (Relapse Prevention)

  This study tests whether higher-dose psilocybin-assisted psychotherapy helps prevent relapse in adults with severe alcohol use disorder and depressive symptoms after detox.

  Recruiting Phase 3 Centre Hospitalier Universitaire de Nīmes · Bayonne and 7 other locations · NCT07638553

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.