drugset / Trial / NCT05494437

Effect of PP-01 on Cannabis Withdrawal Syndrome

NCT05494437

Phase 2 Completed 234 enrolled PleoPharma, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2022-10-27
Primary completion
2023-08-21
Completion
2023-08-21

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gabapentin Small molecule Oral
Comparator Nabilone Other / unclassified Oral
Subject PP-01 Unknown Oral