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PP-01 High Dose for Cannabis Withdrawal

Phase 2
Waitlist Available
Research Sponsored by PleoPharma, Inc.
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 over 5 days
Awards & highlights

Study Summary

This trial will study how effective PP-01 is at reducing cannabis withdrawal symptoms in moderate to severe Cannabis Use Disorder. 225 participants will be monitored over 34 days in 11 visits.

Eligible Conditions
  • Cannabis Withdrawal

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 5 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and over 5 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluation of a patient reported outcome measure of cannabis withdrawal over 5 days

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: PP-01 Low DoseExperimental Treatment1 Intervention
Oral PP-01 Low Dose tapered/titrated over 34 days
Group II: PP-01 High DoseExperimental Treatment1 Intervention
Oral PP-01 High Dose tapered/titrated over 34 days
Group III: NabiloneActive Control1 Intervention
oral nabilone, tapered/titrated over 28 days
Group IV: GabapentinActive Control1 Intervention
oral gabapentin, tapered/titrated over 34 days
Group V: PlaceboPlacebo Group1 Intervention
Oral placebo, given daily for 34 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PP-01 High Dose
2022
Completed Phase 2
~240
PP-01 Low Dose
2022
Completed Phase 2
~240

Find a Location

Who is running the clinical trial?

PleoPharma, Inc.Lead Sponsor
Jay Constantine, MDStudy DirectorPleoPharma, Inc.

Frequently Asked Questions

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

Is the age limit for participants in this research set at 18 years or older?

"The age bracket for people eligible to participate in this trial are those above 18 and below 55 years old."

Answered by AI

Could I take part in this research if I qualified?

"This study is testing the efficacy of a new medication for treating cannabis withdrawal in patients aged 18-55. They are looking to enroll 225 people in total."

Answered by AI

How does PP-01 High Dose rate in terms of patient safety?

"While there is some data suggesting PP-01 High Dose is safe, it only received a score of 2 because this medication has not yet been proven effective."

Answered by AI

Are there several sites running this trial in the metropolitan area?

"According to the latest information, there are 5 locations where this study is currently being conducted. These include iResearch Savannah, LLC in Savannah, Hassman Research Institute in Berlin, and Benchmark Research in Shreveport."

Answered by AI

Are people still being recruited to participate in this research?

"That is correct. The information available on clinicaltrials.gov points to this trial currently being active and looking for participants. This specific trial was posted on October 27th, 2020 and updated on the 28th of that same month. In total, they are seeking 225 individuals from 5 different locations to take part in the study."

Answered by AI

How many test subjects are currently involved in this research project?

"That is correct. The clinicaltrials.gov website has information indicating that the study is still recruiting patients. This research project was posted on October 27th, 2020 and updated on October 28th, 2020; currently, the study needs 225 more participants who will be chosen from 5 different hospitals or clinics."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Virginia
How old are they?
18 - 65
What site did they apply to?
Hassman Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

How much is compensation and also will i be paid for travel time?
PatientReceived no prior treatments

Why did patients apply to this trial?

I have never tried to stop my cannabis habit but am interested to see if ur drug works.
PatientReceived 1 prior treatment
I have recently and in the past tried to quit smoking marijuana but the effects on my nerves gets to me ...its like i need a drag just to function sometimes.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Effect of PP-01 on Cannabis Withdrawal Syndrome
2022. "Effect of PP-01 on Cannabis Withdrawal Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05494437.
~97 spots leftby Apr 2025
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