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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 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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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

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Who is running the clinical trial?

PleoPharma, Inc.Lead Sponsor
Jay Constantine, MDStudy DirectorPleoPharma, Inc.
~78 spots leftby Nov 2025
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