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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
PleoPharma, Inc.
Study ID
NCT07644052
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Cannabis Withdrawal

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • PP-01 — COMBINATION_PRODUCT
    Cannabinoid-1 (CB1) partial agonist / GABAergic modulator
  • Nabilone — DRUG
    CB1 partial agonist
  • Placebo — DRUG
    Placebo comparator

Study Details

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.

Key Dates

First listed
Jun 12, 2026
Start date
Jun 17, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PP-01
    Oral PP-01 tapered/titrated over 34 days
  • Active Comparator: Nabilone
    Oral Nabilone tapered/titrated over 34 days
  • Placebo Comparator: Placebo
    Oral Placebo given daily for 34 days

Primary Outcome Measure

AUCs of the CSCW over Days 2 to 7, inclusive, comparing PP-01 vs Placebo [ Time Frame: Days to 2 to 7 ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
Woodland International Research Group, LLCLittle RockArkansas72211
George Konis, MD (PRINCIPAL_INVESTIGATOR)
Woodland Research Northwest, LLCRogersArkansas72758
Ryan Mahelona, MD (PRINCIPAL_INVESTIGATOR)
Yale Stress CenterNew HavenConnecticut06519
Rajita Sinha, PhD (PRINCIPAL_INVESTIGATOR)
University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - DeLand Clinical Research UnitDeLandFlorida32720
Andrea Marraffino, PhD (PRINCIPAL_INVESTIGATOR)
Research Centers of AmericaHollywoodFlorida33024
Edwin A. Gomez, MD (PRINCIPAL_INVESTIGATOR)
Sandhill Research, LLC d/b/a Accel Research Sites - St. Pete - Largo Clinical Research UnitLargoFlorida33777
Rosario B. Hidalgo, MD (PRINCIPAL_INVESTIGATOR)
ForCare Clinical ResearchTampaFlorida33613
Marlene P. Hart, MD (PRINCIPAL_INVESTIGATOR)
Neuroscience Research InstituteWest Palm BeachFlorida33407
Danesh Alam, MD (PRINCIPAL_INVESTIGATOR)
Sandhill Research, LLC d/b/a Accel Research Sites - NeuroStudies Clinical Research Unit 755DecaturGeorgia30030
Marshall L. Nash, MD, FAHA, CPI, FAPCR (PRINCIPAL_INVESTIGATOR)
Evergreen Clinical TrialsNorcrossGeorgia30092
Dmitriy Pelishev, DO (PRINCIPAL_INVESTIGATOR)
CenExel iResearch, LLCSavannahGeorgia31405
Nancy E. Backus, MD (PRINCIPAL_INVESTIGATOR)
AMR ClinicalLexingtonKentucky40509
Mark S. Adams, MD (PRINCIPAL_INVESTIGATOR)
Maryland Psychiatric Research Center, University of Maryland School of MedicineBaltimoreMaryland21228
David A Gorelick, MD, PhD (PRINCIPAL_INVESTIGATOR)
Oasis Clinical ResearchLas VegasNevada89121
Stephen Tam, MD (PRINCIPAL_INVESTIGATOR)
Hassman Research Institute, LLC d/b/a CenExel Marlton, NJMarltonNew Jersey08053
Elan A. Cohen, PhD (PRINCIPAL_INVESTIGATOR)
The Research Foundation for Mental Hygiene/ New York State Psychiatric InstituteNew YorkNew York10032
John Mariani, MD (PRINCIPAL_INVESTIGATOR)
Richmond Behavioral AssociatesStaten IslandNew York10314
Romana Kulikova, MD (PRINCIPAL_INVESTIGATOR)
Neuro-Behavioral Clinical Research, Inc.North CantonOhio44720
Shishuka Malhotra, MD (PRINCIPAL_INVESTIGATOR)
Coastal Carolina Research Center, LLCNorth CharlestonSouth Carolina29405
Elizabeth Perkins, MD (PRINCIPAL_INVESTIGATOR)
AMR ClinicalKnoxvilleTennessee37920
Jerry L. Punch, MD (PRINCIPAL_INVESTIGATOR)
Memorial Hermann VillageHoustonTexas77043
Dominick Stevan D'Aunno, MD (PRINCIPAL_INVESTIGATOR)

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Woodland International Research Group, LLC· Little Rock, ARWoodland Research Northwest, LLC· Rogers, ARYale Stress Center· New Haven, CTUniversity Clinical Research-DeLand, LLC d/b/a Accel Research Sites - DeLand Clinical Research Unit· DeLand, FLResearch Centers of America· Hollywood, FLSandhill Research, LLC d/b/a Accel Research Sites - St. Pete - Largo Clinical Research Unit· Largo, FL

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