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

2026年9月1日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

420

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：PP-01
Oral PP-01 tapered/titrated over 34 days
组合产品：PP-01
Cannabinoid-1 (CB1) partial agonist / GABAergic modulator
有源比较器：Nabilone
Oral Nabilone tapered/titrated over 34 days
药品：Nabilone
CB1 partial agonist
安慰剂比较：Placebo
Oral Placebo given daily for 34 days
药品：安慰剂
安慰剂对照

研究衡量的是什么？

主要结果指标

结果测量
大体时间
AUCs of the CSCW over Days 2 to 7, inclusive, comparing PP-01 vs Placebo
大体时间：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
大体时间：Days 25 to 35
Days 25 to 35

次要结果测量

结果测量
大体时间
AUCs of CWS-20 Irritability Domain scores over Days 2 to 35 comparing PP-01 vs Placebo
大体时间：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
大体时间：Days 25 to 35
Days 25 to 35
AUCs of the CSCW over Days 2 to 35 comparing PP-01 vs Placebo
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：Days 2 to 7
Days 2 to 7

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

PleoPharma, Inc.

调查人员

  • 研究主任：Jay Constantine, MD、PleoPharma, Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月17日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年9月1日

研究注册日期

首次提交

2026年6月8日

首先提交符合 QC 标准的

2026年6月8日

首次发布 (实际的)

2026年6月12日

研究记录更新

最后更新发布 (实际的)

2026年9月2日

上次提交的符合 QC 标准的更新

2026年9月1日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CAN-004

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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