PT150 for Alcoholism

Overseen By Kelsey Padgett, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Pop Test Oncology LLC

Disqualifiers: Opioid use disorder, Schizophrenia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

34 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether PT150, an experimental treatment, can help with stress and drinking issues in individuals with alcohol use disorder. Researchers aim to determine if PT150 can reduce the effects of stress and alcohol when administered in different sequences. Participants will first receive PT150, then encounter stress and alcohol in varying orders to assess the treatment's impact. Individuals with alcohol use disorder who are not currently seeking treatment and can abstain from alcohol for up to 12 hours before sessions may be suitable for this study. As a Phase 1 trial, this research focuses on understanding how PT150 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to understand any specific requirements.

Is there any evidence suggesting that PT150 is likely to be safe for humans?

Previous studies have shown that PT150 is safe and well-tolerated when taken with alcohol. Research indicates that PT150 and alcohol do not interact harmfully. Participants who have taken PT150 with alcohol have not reported any major side effects, suggesting that PT150 is generally safe for individuals with alcohol use disorder. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for alcoholism?

Researchers are excited about PT150 for alcoholism because it offers a potentially novel approach to treatment. Unlike most current medications for alcoholism, which often target neurotransmitter systems like GABA or opioids, PT150 works by modulating stress pathways. This unique mechanism of action could address the stress-related triggers of alcohol consumption, providing a fresh angle for reducing alcohol use. By offering a different biological target, PT150 might be effective for individuals who haven't responded well to existing treatments like naltrexone or acamprosate.

What evidence suggests that PT150 might be an effective treatment for alcoholism?

Research has shown that PT150 might help with alcohol use disorder by reducing cravings and stress. In animal studies, PT150 eased the physical and behavioral symptoms of alcohol withdrawal, suggesting it might also alleviate withdrawal symptoms in people. Early research found that taking PT150 with alcohol does not cause major interactions, indicating it is safe to use together. In this trial, participants will receive PT150 in different sequences involving alcohol consumption and stress induction to further explore its effects. Although human data remains limited, these findings are promising for PT150 in managing alcohol use disorder. ^{1 2 6 7 8}

Who Is on the Research Team?

Mark Fillmore, PhD

Principal Investigator

Uiversity of Kentucky

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 21-55 with moderate to severe Alcohol Use Disorder (AUD) who aren't seeking treatment and can abstain from alcohol before sessions. They should be generally healthy, have a normal heart reading, not use drugs other than tobacco, and women must use birth control. People with serious diseases or significant mental health issues cannot join.

Inclusion Criteria

English-speaking

ECG, read by cardiologist, within normal limits

Meet diagnostic criteria for AUD (moderate or severe) per the Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM-5)

Exclusion Criteria

Are unwilling/unable to comply with study procedures

I have a serious or current physical illness.

Participants scoring >6 on the Clinical Institute Withdrawal Assessment for Alcohol Revised (CIWA-Ar)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Maintenance

Participants are maintained on a randomized dose of PT150 for at least five days before experimental sessions

1 week

Alcohol Administration Session

Participants receive a single administration of alcohol and are monitored for behavioral and physiological effects

1 day

1 visit (in-person)

Stress Induction Session

Participants undergo a stress-induction procedure using the Cold Pressure Test and are monitored for behavioral and neuroendocrinological responses

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PT150

Trial Overview The study tests if PT150 can lessen stress and alcohol's effects in those with AUD. Participants will undergo stress-induction procedures while their reactions to alcohol are observed. The aim is to see if PT150 helps manage the behavioral and physical impacts of stress related to alcohol consumption.

How Is the Trial Designed?

Group I: PT150 with stress then alcohol consumption Experimental Treatment 3 Interventions

Following at least five days of maintenance on a randomized dose of PT150, participants will complete an experimental session involving stress induction. No less than 24 hours later, participants will then complete an experimental alcohol administration session.

Group II: PT150 with alcohol consumption then stress Experimental Treatment 3 Interventions

Following at least five days of maintenance on a randomized dose of PT150, participants will complete an experimental alcohol administration session. No less than 24 hours later, participants will then complete an experimental stress induction session.

Who Is Running the Clinical Trial?

Pop Test Oncology LLC

Lead Sponsor

Trials

3

Recruited

50+

University of Kentucky

Collaborator

Trials

198

Recruited

224,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06712602

NCT06712602 | PT150 Drug for Use in Alcohol Use Disorder The Investigators predict: 1) stress induction will increase cortisol, alcohol demand and negative mood, and PT150 will attenuate these responses, 2) alcohol ...

2. nature.com nature.com/articles/s41598-021-88609-6

A randomized trial of safety and pharmacodynamic ... In mice, PT150 reduced both the physiological severity and behavioral effects of alcohol withdrawal following binge-like ethanol administration ...

3. reporter.nih.gov reporter.nih.gov/search/mR8A9QNp0E-HWEwkLH-7Mw/project-details/11142470

A Human Neuroscience Study Finally, we will determine whether PT150 reduces ALC use (i.e., number of drinks and heavy drinking days/week), craving, and stress in the natural ecology.

4. ovid.com ovid.com/journals/jamed/fulltext/10.1097/adm.0000000000001557~pharmacokinetic-interactions-between-ethanol-and-pt150-a

Pharmacokinetic Interactions Between Ethanol and PT150 ... These data suggest that coadministration of PT150 and alcohol does not produce significant pharmacokinetic interactions, supporting the ...

5. firstwordpharma.com firstwordpharma.com/story/5990485

Palisades Therapeutics Announces Groundbreaking ... "PT150's demonstrated safety when combined with alcohol clears the path for larger Phase II efficacy trials and brings us significantly closer ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40794488/

Pharmacokinetic Interactions Between Ethanol and PT150, ... Conclusions: These data suggest that coadministration of PT150 and alcohol does not produce significant pharmacokinetic interactions, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03548714

Study Details | NCT03548714 | Clinical Trial to Evaluate ... The purpose of the clinical study is to compare pharmacodynamic and safety endpoints following an alcohol challenge prior to and concurrent with PT150 (study ...

8. researchgate.net researchgate.net/publication/351455017_A_randomized_trial_of_safety_and_pharmacodynamic_interactions_between_a_selective_glucocorticoid_receptor_antagonist_PT150_and_ethanol_in_healthy_volunteers

(PDF) A randomized trial of safety and pharmacodynamic ... These data show that administration of PT150 with concurrent alcohol use is safe and well-tolerated. This study supports a future ...