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Effect of PP-01 on Cannabis Withdrawal Syndrome

NCT05494437 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2024-08-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • PleoPharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Jay Constantine, MD · PleoPharma, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-27
Primary Completion
2023-08-21
Completion
2023-08-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05494437 on ClinicalTrials.gov