Your session is about to expire
← Back to Search
Other
Effect of PP-01 on Cannabis Withdrawal Syndrome
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 up to 5 years
Summary
This trial is testing a medication called PP-01 to see if it can help people with severe cannabis use disorder feel better when they quit using cannabis. The study involves 225 participants and aims to reduce the uncomfortable withdrawal symptoms they experience.
Eligible Conditions
- Cannabis Withdrawal
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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 Low Dose
2022
Completed Phase 2
~240
PP-01 High Dose
2022
Completed Phase 2
~240
Find a Location
Who is running the clinical trial?
PleoPharma, Inc.Lead Sponsor
Jay Constantine, MDStudy DirectorPleoPharma, Inc.