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Recruiting Phase 3 Interventional

Efficacy of PP-01 in Mitigating Cannabis Withdrawal Symptoms in Adults With Cannabis Use Disorder

ClinicalTrials.gov ID: NCT07644052

Public ClinicalTrials.gov record NCT07644052. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 10, 2026, 12:40 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled Clinical Trial of Titrating Doses of PP-01 for the Mitigation of Cannabis Withdrawal Symptoms in Adults With Cannabis Use Disorder: Core Study With Safety Extension Phase

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study is a randomized, double-blind, placebo and active-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). Study participants will receive PP-01, nabilone, or placebo every day for 34 days. The total study duration will be approximately 78 days, including screening and a one-week inpatient stay. Following the initial inpatient portion of the study, participants will return to the clinic for six clinic visits and complete two telemedicine appointments. Participants will complete daily symptom diaries and other study-related questionnaires. Participants who complete the core study may be eligible to participate in a repeat dosing extension study if they meet required criteria.

Study identification

NCT ID
NCT07644052
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
PleoPharma, Inc.
Industry
Enrollment
420 participants

Conditions and interventions

Interventions

Combination Product · Drug

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 16, 2026
Primary completion
May 31, 2027
Completion
Aug 31, 2027
Last update posted
Sep 1, 2026

2026 – 2027

United States locations

U.S. sites
22
U.S. states
13
U.S. cities
22
Facility City State ZIP Site status
Woodland International Research Group, LLC Little Rock Arkansas 72211 Recruiting
Woodland Research Northwest, LLC Rogers Arkansas 72758 Recruiting
Yale Stress Center New Haven Connecticut 06519 Recruiting
University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - DeLand Clinical Research Unit DeLand Florida 32720 Recruiting
Research Centers of America Hollywood Florida 33024 Recruiting
Sandhill Research, LLC d/b/a Accel Research Sites - St. Pete - Largo Clinical Research Unit Largo Florida 33777 Recruiting
ForCare Clinical Research Tampa Florida 33613 Recruiting
Neuroscience Research Institute West Palm Beach Florida 33407 Recruiting
Sandhill Research, LLC d/b/a Accel Research Sites - NeuroStudies Clinical Research Unit 755 Decatur Georgia 30030 Recruiting
Evergreen Clinical Trials Norcross Georgia 30092 Recruiting
CenExel iResearch, LLC Savannah Georgia 31405 Recruiting
AMR Clinical Lexington Kentucky 40509 Recruiting
Maryland Psychiatric Research Center, University of Maryland School of Medicine Baltimore Maryland 21228 Recruiting
Oasis Clinical Research Las Vegas Nevada 89121 Recruiting
Hassman Research Institute, LLC d/b/a CenExel Marlton, NJ Marlton New Jersey 08053 Recruiting
The Research Foundation for Mental Hygiene/ New York State Psychiatric Institute New York New York 10032 Recruiting
Richmond Behavioral Associates Staten Island New York 10314 Recruiting
Neuro-Behavioral Clinical Research, Inc. North Canton Ohio 44720 Recruiting
Coastal Carolina Research Center, LLC North Charleston South Carolina 29405 Recruiting
AMR Clinical Knoxville Tennessee 37920 Recruiting
Community Clinical Research, Inc. Austin Texas 78754 Recruiting
Memorial Hermann Village Houston Texas 77043 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07644052, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 1, 2026 · Synced Sep 10, 2026

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The complete protocol, eligibility criteria, and contact information for NCT07644052 live on ClinicalTrials.gov.

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