NCT05494437

Effect of PP-01 on Cannabis Withdrawal Syndrome

A Phase 2, Multicenter, Randomized, Double-Blind, Multiple-Dose, Placebo Controlled Clinical Trial of Two Doses of PP-01 for the Mitigation of Cannabis Withdrawal Symptoms

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: PleoPharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cannabis Withdrawal

Interventions

Type	Name	Description
COMBINATION_PRODUCT	PP-01 High Dose	Cannabinoid-1 (CB1) partial agonist / GABAergic modulator
COMBINATION_PRODUCT	PP-01 Low Dose	CB1 partial agonist / GABAergic modulator
DRUG	Placebo	Placebo comparator
DRUG	Nabilone	CB1 receptor
DRUG	Gabapentin	GABAergic modulator

Timeline

• Start date: 2022-10-27
• Primary completion: 2023-08-21
• Completion: 2023-08-21
• First posted: 2022-08-10
• Last updated: 2024-08-16

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study