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

1 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

420

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: PleoPharma, Inc.
  • Número de teléfono: 610-937-2882
  • Correo electrónico: jcon@pleopharma.com

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: PP-01
Oral PP-01 tapered/titrated over 34 days
Producto combinado: PP-01
Cannabinoid-1 (CB1) partial agonist / GABAergic modulator
Comparador activo: Nabilone
Oral Nabilone tapered/titrated over 34 days
Droga: Nabilone
CB1 partial agonist
Comparador de placebos: Placebo
Oral Placebo given daily for 34 days
Droga: Placebo
Comparador de placebos

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
AUCs of the CSCW over Days 2 to 7, inclusive, comparing PP-01 vs Placebo
Periodo de tiempo: 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
Periodo de tiempo: Days 25 to 35
Days 25 to 35

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
AUCs of CWS-20 Irritability Domain scores over Days 2 to 35 comparing PP-01 vs Placebo
Periodo de tiempo: 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
Periodo de tiempo: Days 25 to 35
Days 25 to 35
AUCs of the CSCW over Days 2 to 35 comparing PP-01 vs Placebo
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Days 2 to 7
Days 2 to 7

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

PleoPharma, Inc.

Investigadores

  • Director de estudio: Jay Constantine, MD, PleoPharma, Inc.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

17 de junio de 2026

Finalización primaria (Estimado)

1 de junio de 2027

Finalización del estudio (Estimado)

1 de septiembre de 2027

Fechas de registro del estudio

Enviado por primera vez

8 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

8 de junio de 2026

Publicado por primera vez (Actual)

12 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CAN-004

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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