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Study identifier: NCT07644052 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Cannabis Withdrawal  ·  Sponsor: PleoPharma, Inc.

PhasePhase 3
Planned participants420
Who can joinAll sexes, 18 Years to 55 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

LBR Regulatory  ·  859-426-5035  ·  lois.rosenberger@lbria.com

PleoPharma, Inc.  ·  610-937-2882  ·  jcon@pleopharma.com

Always discuss trial participation with your own doctor first.

Locations (21)

Woodland International Research Group, LLCLittle Rock, Arkansas, United StatesRecruiting
Woodland Research Northwest, LLCRogers, Arkansas, United StatesRecruiting
Yale Stress CenterNew Haven, Connecticut, United StatesRecruiting
University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - DeLand Clinical Research UnitDeLand, Florida, United StatesRecruiting
Research Centers of AmericaHollywood, Florida, United StatesRecruiting
Sandhill Research, LLC d/b/a Accel Research Sites - St. Pete - Largo Clinical Research UnitLargo, Florida, United StatesRecruiting
ForCare Clinical ResearchTampa, Florida, United StatesRecruiting
Neuroscience Research InstituteWest Palm Beach, Florida, United StatesRecruiting
Sandhill Research, LLC d/b/a Accel Research Sites - NeuroStudies Clinical Research Unit 755Decatur, Georgia, United StatesRecruiting
Evergreen Clinical TrialsNorcross, Georgia, United StatesRecruiting
CenExel iResearch, LLCSavannah, Georgia, United StatesRecruiting
AMR ClinicalLexington, Kentucky, United StatesRecruiting

+ 9 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07644052