PP-01 High Dose for Cannabis Withdrawal

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cannabis Withdrawal+1 More
PP-01 High Dose - CombinationProduct
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This study will be a randomized, double-blind, placebo-controlled, multicenter trial conducted to evaluate whether PP-01 mitigates the withdrawal symptoms associated with discontinuing cannabis in participants with moderate to severe Cannabis Use Disorder (CUD). The study will enroll approximately 225 participants with moderate to severe CUD and will include 5 arms, including a placebo arm, to help assess the incidence and severity of withdrawal symptoms in heavy long-term users of cannabis. Participants receive study medication for 34 days and participate in 11 visits (7 at a clinic and 4 telemedicine).

Eligible Conditions
  • Cannabis Withdrawal

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Over 5 days

Over 5 days
Substance Withdrawal Syndrome
Evaluation of a patient reported outcome measure of cannabis withdrawal over 5 days

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

5 Treatment Groups

Nabilone
1 of 5
Gabapentin
1 of 5
PP-01 High Dose
1 of 5
PP-01 Low Dose
1 of 5
Placebo
1 of 5
Active Control
Experimental Treatment
Non-Treatment Group

225 Total Participants · 5 Treatment Groups

Primary Treatment: PP-01 High Dose · Has Placebo Group · Phase 2

PP-01 High Dose
CombinationProduct
Experimental Group · 1 Intervention: PP-01 High Dose · Intervention Types: CombinationProduct
PP-01 Low Dose
CombinationProduct
Experimental Group · 1 Intervention: PP-01 Low Dose · Intervention Types: CombinationProduct
Nabilone
Drug
ActiveComparator Group · 1 Intervention: Nabilone · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Gabapentin
Drug
ActiveComparator Group · 1 Intervention: Gabapentin · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: over 5 days

Who is running the clinical trial?

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

Eligibility Criteria

Age 18 - 65 · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are generally healthy.\n
You have a current diagnosis of moderate to severe CUD as confirmed by a licensed physician or psychologist or addiction medicine specialist.
You have a body mass index (BMI) of 18.0 to 38.0 kg/m2, inclusive.
You are seeking to discontinue cannabis use because of withdrawal symptoms.
You are willing to comply with all study procedures including twice weekly visits, daily evening video calls, restrictions, and availability for the duration of the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: October 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
New Jersey100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Hassman Research Institute100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "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"
What questions have other patients asked about this trial?
  • "How much is compensation and also will i be paid for travel time?"
How many prior treatments have patients received?
0100.0%