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

1 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

420

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: PP-01
Oral PP-01 tapered/titrated over 34 days
Produit combiné: PP-01
Cannabinoid-1 (CB1) partial agonist / GABAergic modulator
Comparateur actif: Nabilone
Oral Nabilone tapered/titrated over 34 days
Médicament: Nabilone
CB1 partial agonist
Comparateur placebo: Placebo
Oral Placebo given daily for 34 days
Médicament: Placebo
Comparateur placebo

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
AUCs of the CSCW over Days 2 to 7, inclusive, comparing PP-01 vs Placebo
Délai: 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
Délai: Days 25 to 35
Days 25 to 35

Mesures de résultats secondaires

Mesure des résultats
Délai
AUCs of CWS-20 Irritability Domain scores over Days 2 to 35 comparing PP-01 vs Placebo
Délai: 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
Délai: Days 25 to 35
Days 25 to 35
AUCs of the CSCW over Days 2 to 35 comparing PP-01 vs Placebo
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Days 2 to 7
Days 2 to 7

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

PleoPharma, Inc.

Les enquêteurs

  • Directeur d'études: Jay Constantine, MD, PleoPharma, Inc.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

17 juin 2026

Achèvement primaire (Estimé)

1 juin 2027

Achèvement de l'étude (Estimé)

1 septembre 2027

Dates d'inscription aux études

Première soumission

8 juin 2026

Première soumission répondant aux critères de contrôle qualité

8 juin 2026

Première publication (Réel)

12 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CAN-004

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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