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

1 de setembro de 2026 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

420

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: PP-01
Oral PP-01 tapered/titrated over 34 days
Produto combinado: PP-01
Cannabinoid-1 (CB1) partial agonist / GABAergic modulator
Comparador Ativo: Nabilone
Oral Nabilone tapered/titrated over 34 days
Medicamento: Nabilone
CB1 partial agonist
Comparador de Placebo: Placebo
Oral Placebo given daily for 34 days
Medicamento: Placebo
Comparador de placebo

O que o estudo está medindo?

Medidas de resultados primários

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

Medidas de resultados secundários

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

PleoPharma, Inc.

Investigadores

  • Diretor de estudo: Jay Constantine, MD, PleoPharma, Inc.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

17 de junho de 2026

Conclusão Primária (Estimado)

1 de junho de 2027

Conclusão do estudo (Estimado)

1 de setembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

8 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de junho de 2026

Primeira postagem (Real)

12 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

2 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CAN-004

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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