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

Part of paid clinical trials in DeLand, Florida.

Sponsor
PleoPharma, Inc.
Study ID
NCT07644052
Phase
PHASE3
Status
Recruiting
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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

Start date
Jun 30, 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 (8)

FacilityCityStateZIPSite coordinators
University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - DeLand Clinical Research UnitDeLandFlorida32720
Andrea Marraffino, PhD (PRINCIPAL_INVESTIGATOR)
Sandhill Research, LLC d/b/a Accel Research Sites - NeuroStudies Clinical Research Unit 755LargoFlorida33777
Rosario B. Hidalgo, MD (PRINCIPAL_INVESTIGATOR)
ForCare Clinical ResearchTampaFlorida33613
Marlene P. Hart, 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)
CenExel iResearch, LLCSavannahGeorgia31405
Nancy E. Backus, 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)
AMR ClinicalKnoxvilleTennessee37920
Jerry L. Punch, MD (PRINCIPAL_INVESTIGATOR)

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University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - DeLand Clinical Research Unit· DeLand, FLSandhill Research, LLC d/b/a Accel Research Sites - NeuroStudies Clinical Research Unit 755· Largo, FLForCare Clinical Research· Tampa, FLSandhill Research, LLC d/b/a Accel Research Sites - NeuroStudies Clinical Research Unit 755· Decatur, GACenExel iResearch, LLC· Savannah, GARichmond Behavioral Associates· Staten Island, NY

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