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

1 september 2026 bijgewerkt door: PleoPharma, Inc.

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

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

420

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • Arkansas
      • Little Rock, Arkansas, Verenigde Staten, 72211
        • Werving
        • Woodland International Research Group, LLC
        • Hoofdonderzoeker:
          • George Konis, MD
      • Rogers, Arkansas, Verenigde Staten, 72758
        • Werving
        • Woodland Research Northwest, LLC
        • Hoofdonderzoeker:
          • Ryan Mahelona, MD
    • Connecticut
      • New Haven, Connecticut, Verenigde Staten, 06519
        • Werving
        • Yale Stress Center
        • Hoofdonderzoeker:
          • Rajita Sinha, PhD
    • Florida
      • DeLand, Florida, Verenigde Staten, 32720
        • Werving
        • University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - DeLand Clinical Research Unit
        • Hoofdonderzoeker:
          • Bruce G. Rankin, DO
      • Hollywood, Florida, Verenigde Staten, 33024
        • Werving
        • Research Centers of America
        • Hoofdonderzoeker:
          • Edwin A. Gomez, MD
      • Largo, Florida, Verenigde Staten, 33777
        • Werving
        • Sandhill Research, LLC d/b/a Accel Research Sites - St. Pete - Largo Clinical Research Unit
        • Hoofdonderzoeker:
          • Rosario B. Hidalgo, MD
      • Tampa, Florida, Verenigde Staten, 33613
        • Werving
        • ForCare Clinical Research
        • Hoofdonderzoeker:
          • Marlene P. Hart, MD
      • West Palm Beach, Florida, Verenigde Staten, 33407
        • Werving
        • Neuroscience Research Institute
        • Hoofdonderzoeker:
          • Danesh Alam, MD
    • Georgia
      • Decatur, Georgia, Verenigde Staten, 30030
        • Werving
        • Sandhill Research, LLC d/b/a Accel Research Sites - NeuroStudies Clinical Research Unit 755
        • Hoofdonderzoeker:
          • Marshall L. Nash, MD, FAHA, CPI, FAPCR
      • Norcross, Georgia, Verenigde Staten, 30092
        • Werving
        • Evergreen Clinical Trials
        • Hoofdonderzoeker:
          • Dmitriy Pelishev, DO
      • Savannah, Georgia, Verenigde Staten, 31405
        • Werving
        • CenExel iResearch, LLC
        • Hoofdonderzoeker:
          • Nancy E. Backus, MD
    • Kentucky
      • Lexington, Kentucky, Verenigde Staten, 40509
        • Werving
        • AMR Clinical
        • Hoofdonderzoeker:
          • Peter Akpunonu, MD
    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21228
        • Werving
        • Maryland Psychiatric Research Center, University of Maryland School of Medicine
        • Hoofdonderzoeker:
          • David A Gorelick, MD, PhD
    • Nevada
      • Las Vegas, Nevada, Verenigde Staten, 89121
        • Werving
        • Oasis Clinical Research
        • Hoofdonderzoeker:
          • Stephen Tam, MD
    • New Jersey
      • Marlton, New Jersey, Verenigde Staten, 08053
        • Werving
        • Hassman Research Institute, LLC d/b/a CenExel Marlton, NJ
        • Hoofdonderzoeker:
          • Elan A. Cohen, PhD
    • New York
      • New York, New York, Verenigde Staten, 10032
        • Werving
        • The Research Foundation for Mental Hygiene/ New York State Psychiatric Institute
        • Hoofdonderzoeker:
          • John Mariani, MD
      • Staten Island, New York, Verenigde Staten, 10314
        • Werving
        • Richmond Behavioral Associates
        • Hoofdonderzoeker:
          • Romana Kulikova, MD
    • Ohio
      • North Canton, Ohio, Verenigde Staten, 44720
        • Werving
        • Neuro-Behavioral Clinical Research, Inc.
        • Hoofdonderzoeker:
          • Shishuka Malhotra, MD
    • South Carolina
      • North Charleston, South Carolina, Verenigde Staten, 29405
        • Werving
        • Coastal Carolina Research Center, LLC
        • Hoofdonderzoeker:
          • Elizabeth Perkins, MD
    • Tennessee
      • Knoxville, Tennessee, Verenigde Staten, 37920
        • Werving
        • AMR Clinical
        • Hoofdonderzoeker:
          • Jerry L. Punch, MD
    • Texas
      • Austin, Texas, Verenigde Staten, 78754
        • Werving
        • Community Clinical Research, Inc.
        • Hoofdonderzoeker:
          • David Brown, MD
      • Houston, Texas, Verenigde Staten, 77043
        • Werving
        • Memorial Hermann Village
        • Hoofdonderzoeker:
          • Dominick Stevan D'Aunno, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  1. Generally healthy adults between the ages of 18 and 55, inclusive.
  2. Meet DSM-5 diagnostic criteria for current moderate to severe CUD as confirmed by a licensed physician or psychologist or addiction medicine specialist.
  3. BMI within 18.0 to 38.0 kg/m2, inclusive.
  4. Female participants must not be pregnant or lactating. If of childbearing potential - the participant agrees to use an accepted contraceptive regimen.
  5. Male participants who are fertile and engage in sexual activity must agree to use a double barrier method (e.g., condom and spermicide) during the study and to not donate sperm for 90 days after the last dose of study medication.
  6. Be seeking and motivated to discontinue cannabis and to minimize withdrawal symptoms.
  7. Agree to not use cannabis or any product containing CBD, hemp derivatives, terpenes or any THC containing product including delta-8, delta-10, THC-A or any other cannabinoid-like product following Randomization and throughout the study duration.
  8. Meet DSM-5 Cannabis Withdrawal Criteria.
  9. Report heavy use of daily/near daily cannabis.
  10. Have a urine drug screen positive for THC/THC metabolite and have a negative result for all other illicit/excluded drugs and alcohol at Screening and Randomization.
  11. Capable of giving informed consent and stated willingness to comply with all study procedures including inpatient and weekly outpatient visits, daily evening video calls, restrictions, and availability for the duration of the study.
  12. Willing to be admitted to an inpatient clinic with overnight stays on Days 1 through 6 and return for all outpatient visits.
  13. Ability to take study drug capsules at approximately the same time each day.
  14. Have regular access to the internet and access to video/virtual capabilities for video calls by any means.
  15. Agree to not use any alcohol during the study.
  16. No plan to change current nicotine use.
  17. Ability to read, understand, and complete daily diaries.

Exclusion Criteria:

  1. Lifetime history of DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder.
  2. Current DSM-5 criteria for a psychiatric disorder that in the Investigator's judgment is unstable, would be disrupted by the study medication, or is likely to require new pharmacotherapy or psychotherapy during the study period. Individuals who are currently stable on psychotropic medication for at least 3 months may be included at the discretion of the Investigator's judgement.
  3. Participants who meet DSM-5 criteria for any history of or current drug use disorder within the previous 2 years, other than cannabis, nicotine, or caffeine use disorders.
  4. Participants who consume alcohol on a regular or frequent basis and who do not agree or are deemed by the Investigator to be unable to discontinue alcohol for the duration of the study.
  5. Participants using cannabis for a physician directed medical condition requiring use such as epilepsy.
  6. Any clinically important abnormalities on Screening physical examination, assessments, electrocardiogram, or laboratory tests.
  7. Current or recent history of significant violent or suicidal behavior, risk for suicide or homicide.
  8. History of clinically significant medical condition that, in the opinion of the Principal Investigator, would jeopardize the safety of the participant or impact on the validity of the study results.
  9. Participants with risk factors for seizure.
  10. Known history of allergy, intolerance, or hypersensitivity to nabilone, gabapentin, or pregabalin.

  11. Prohibited medications at Screening:

    • Current use of narcotics, psychedelics, stimulants, opioid agonists and antagonists, kratom, illicit drugs, ketamine, unregulated psychoactive drugs (sometimes known as "gas station drugs"), or products intended to induce a feeling of being high except for cannabis
    • Regular benzodiazepine use (more than once per week) and no use within 7 days of Baseline Visit (Day 1)
    • Current use (within 7 days of Baseline Visit) of OTC products to help with sleep or anxiety
    • Prescription medications to help with sleep or anxiety within 14 days of Screening
    • Current use of nabilone, dronabinol, Sativex, Epidiolex, synthetic cannabinoids
    • Gabapentin or pregabalin or use within 30 days of Screening
  12. Heavy users of alcohol within 60 days of Screening or binge drinkers of alcohol within 30 days of Screening.
  13. A positive urine drug/alcohol test at Screening or Randomization for narcotics and/or illicit drugs other than cannabis. If the test is positive for benzodiazepines or alcohol at Screening, and if it is reported that they are only occasional users, a repeat urine drug screen can be performed at the discretion of the Medical Monitor and must be negative at the time of Randomization.
  14. Use of an investigational drug or biologic within 30 days or 5 times the half-life (whichever is longer) prior to the Screening Visit.
  15. Active influenza or COVID-19 infection or planned vaccination.
  16. Prior participation in any PleoPharma clinical study.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: PP-01
Oral PP-01 tapered/titrated over 34 days
Combinatie product: PP-01
Cannabinoid-1 (CB1) partial agonist / GABAergic modulator
Actieve vergelijker: Nabilone
Oral Nabilone tapered/titrated over 34 days
Geneesmiddel: Nabilone
CB1 partial agonist
Placebo-vergelijker: Placebo
Oral Placebo given daily for 34 days
Geneesmiddel: Placebo
Placebo-vergelijker

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
AUCs of the CSCW over Days 2 to 7, inclusive, comparing PP-01 vs Placebo
Tijdsspanne: Days to 2 to 7
Days to 2 to 7
AUCs of the CSCW over Days 25 to 35, inclusive, comparing PP-01 vs Nabilone to assess rebound
Tijdsspanne: Days 25 to 35
Days 25 to 35

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
AUCs of CWS-20 Irritability Domain scores over Days 2 to 35 comparing PP-01 vs Placebo
Tijdsspanne: Days 2 to 35
Days 2 to 35
AUCs of CWS-20 Irritability Domain scores over Days 25 to 35 comparing PP-01 vs Nabilone
Tijdsspanne: Days 25 to 35
Days 25 to 35
AUCs of the CSCW over Days 2 to 35 comparing PP-01 vs Placebo
Tijdsspanne: Days 2 to 35
Days 2 to 35
AUCs of CWS-20 Sleep Domain scores over Days 2 to 35 comparing PP-01 vs Placebo
Tijdsspanne: Days 2 to 35
Days 2 to 35
AUCs of CWS-20 Sleep Domain scores over Days 2 to 7 comparing PP-01 vs Placebo
Tijdsspanne: Days 2 to 7
Days 2 to 7
AUCs of CWS-20 Craving Domain scores over Days 2 to 35 comparing PP-01 vs Placebo
Tijdsspanne: Days 2 to 35
Days 2 to 35
AUCs of CWS-20 Craving Domain scores over Days 2 to 7 comparing PP-01 vs Placebo
Tijdsspanne: Days 2 to 7
Days 2 to 7

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

PleoPharma, Inc.

Onderzoekers

  • Studie directeur: Jay Constantine, MD, PleoPharma, Inc.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

17 juni 2026

Primaire voltooiing (Geschat)

1 juni 2027

Studie voltooiing (Geschat)

1 september 2027

Studieregistratiedata

Eerst ingediend

8 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

8 juni 2026

Eerst geplaatst (Werkelijk)

12 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 september 2026

Laatste update ingediend die voldeed aan QC-criteria

1 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CAN-004

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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