← Back to Search

Other

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

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.
~88 spots leftby Jul 2025