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Unknown

PT150 with alcohol consumption for Alcohol Treatment

Phase 1
Waitlist Available
Led By Christopher Verrico, PhD
Research Sponsored by Pop Test Oncology LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up an ecg measurement is taken once on day 1 prior to ethanol and pt150 exposure, followed by measurements on days 2, 5, 6, 7, 8, and 9 (all post-pt150 exposure measurements).
Awards & highlights

Study Summary

This trial will study how alcohol interacts with the drug PT150 given to people who have experience with alcohol.

Eligible Conditions
  • Alcohol Interaction Treatment

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~adverse events are reported throughout the study, from enrollment to study completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and adverse events are reported throughout the study, from enrollment to study completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in area under the concentration-time curve of PT150 (AUCPT150)
Difference in maximum concentration of PT150 (CmaxPT150)
Difference in terminal elimination half-life of PT150 (t1/2PT150)
+1 more
Secondary outcome measures
Change in ECG abnormalities
Change in severity of alcohol withdrawal symptom severity as measured on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar)
Difference in diastolic blood pressure
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: PT150 with alcohol consumptionExperimental Treatment2 Interventions
Study drug to be administered as a single, fixed dose over a 5-day period. An alcohol challenge will be completed on day 1 (pre-treatment) followed by blood draws over a 24-hour period. PT150 dosing will begin on study day 2 and continue until steady state is reached on day 6, at which point blood draws will occur over a 24-hour period. On day 7, after PT150 steady state has been achieved, an alcohol challenge will be completed followed by blood draws over a 40-hour period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PT150
2021
Completed Phase 1
~20

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Pop Test Oncology LLCLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
Congressionally Directed Medical Research ProgramsFED
46 Previous Clinical Trials
7,054 Total Patients Enrolled
Baylor College of MedicineOTHER
997 Previous Clinical Trials
6,002,009 Total Patients Enrolled

Media Library

PT150 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT04331288 — Phase 1
Alcohol Treatment Research Study Groups: PT150 with alcohol consumption
Alcohol Treatment Clinical Trial 2023: PT150 Highlights & Side Effects. Trial Name: NCT04331288 — Phase 1
PT150 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04331288 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could the concurrent ingestion of PT150 and alcohol be potentially risky?

"PT150's safety when combined with alcohol is rated a 1; this reflects the fact that there is limited data available concerning its efficacy and how it interacts with other substances."

Answered by AI

What core aims is this clinical trial hoping to achieve?

"This clinical trial aims to determine the difference in time of one-half the maximum concentration of PT150 (t1/2PT150) over a given period. Secondary objectives include assessing the differences in t1/2EtOH, ECG abnormalities and diastolic blood pressure from ethanol alone to concurrent steady state of PT150 with ethanol exposure."

Answered by AI

Is the age restriction for this experiment higher than seventy-five years?

"Appropriate applicants for this trial should be between the ages of 21 and 64."

Answered by AI

What is the participant count for this experiment?

"Affirmative. Clinicaltrials.gov corroborates the fact that this medical trial, which was initially published on November 1st 2021, is still actively seeking participants. The study needs to recruit 10 individuals from a single site."

Answered by AI

How is PT150 commonly employed in conjunction with alcohol consumption?

"Obstructive hypertrophic cardiomyopathy is typically managed with PT150 and alcohol consumption. Furthermore, this protocol may be beneficial for treating communicable diseases, ethylene glycol intoxication, and skin disinfection therapy."

Answered by AI

Are there still vacancies for volunteers in this medical research?

"According to clinicaltrials.gov, this trial is in the process of recruiting participants. The initial posting was on November 1st 2021 and it most recently updated on September 26th 2022."

Answered by AI

What qualifications must be met in order to participate in this clinical experiment?

"This clinical trial seeks to recruit 10 individuals who are suffering from alcoholism and aged 21-64. Applicants must have a CIWA-Ar score of less than 10, consent to comply with all study proceedings, be able to provide proof of age and identity, not need medical detoxification as evidenced by a BAL ≤ 0.00%, not possess any clinically significant contraindications for study participation in the judgement of the admitting physician (as determined through self reported history and physical examination), women should either be sterile or use non-hormonal contraception during the course of the study plus two weeks after completion if they are capable of conceiving while"

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Michael E. DeBakey Veterans Affairs Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
0
2

Why did patients apply to this trial?

How responsive is this trial?

Most responsive sites:
  1. Michael E. DeBakey Veterans Affairs Medical Center: < 24 hours
Average response time
  • < 1 Day
Typically responds via
Phone Call
~3 spots leftby Mar 2025