Effect of PP-01 on Cannabis Withdrawal Syndrome
Recruiting in Palo Alto (17 mi)
+18 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: PleoPharma, Inc.
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Research Team
JC
Jay Constantine, MD
Principal Investigator
PleoPharma, Inc.
Eligibility Criteria
Inclusion Criteria
Your body mass index (BMI) falls between 18.0 and 38.0 kg/m2.
Report heavy use of daily/near daily cannabis
Have a urine drug screen positive for tetrahydrocannabinol (THC)/THC metabolites at Screening and Randomization
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Exclusion Criteria
You have been diagnosed with schizophrenia or schizoaffective disorder or bipolar 1 within the past 2 years.
You have a mental health condition that is currently unstable or may be affected by the study medication. If you have been taking medication for a stable condition for at least 3 months, the Investigator may decide to include you in the study.
You have a serious medical condition that is not under control.
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Treatment Details
Interventions
- PP-01 (Other)
Participant Groups
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
PleoPharma, Inc.
Lead Sponsor
Trials
1
Recruited
230+