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Effect of PP-01 on Cannabis Withdrawal Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05494437
Recruitment Status : Not yet recruiting
First Posted : August 10, 2022
Last Update Posted : August 12, 2022
Sponsor:
Information provided by (Responsible Party):
PleoPharma, Inc.

Brief Summary:
This study will be a randomized, double-blind, placebo-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). The study will enroll approximately 225 participants with moderate to severe CUD and will include 5 arms, including a placebo arm, to help assess the incidence and severity of withdrawal symptoms in heavy long-term users of cannabis. Participants receive study medication for 34 days and participate in 11 visits (7 at a clinic and 4 telemedicine).

Condition or disease Intervention/treatment Phase
Cannabis Withdrawal Combination Product: PP-01 High Dose Combination Product: PP-01 Low Dose Drug: Placebo Drug: Nabilone Drug: Gabapentin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-Blind, Multiple-Dose, Placebo Controlled Clinical Trial of Two Doses of PP-01 for the Mitigation of Cannabis Withdrawal Symptoms
Estimated Study Start Date : August 2022
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Experimental: PP-01 High Dose
Oral PP-01 High Dose tapered/titrated over 34 days
Combination Product: PP-01 High Dose
Cannabinoid-1 (CB1) partial agonist / GABAergic modulator

Experimental: PP-01 Low Dose
Oral PP-01 Low Dose tapered/titrated over 34 days
Combination Product: PP-01 Low Dose
CB1 partial agonist / GABAergic modulator

Placebo Comparator: Placebo
Oral placebo, given daily for 34 days
Drug: Placebo
Placebo comparator

Active Comparator: Nabilone
oral nabilone, tapered/titrated over 28 days
Drug: Nabilone
CB1 receptor

Active Comparator: Gabapentin
oral gabapentin, tapered/titrated over 34 days
Drug: Gabapentin
GABAergic modulator




Primary Outcome Measures :
  1. Evaluation of a patient reported outcome measure of cannabis withdrawal over 5 days [ Time Frame: Over 5 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Generally healthy individuals between the ages of 18 and 55, inclusive
  2. Meets Diagnostic and Statistical Manual (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. Seeking to minimize withdrawal symptoms related to cannabis discontinuation in people seeking to discontinue cannabis
  5. Meet DSM-5 Cannabis Withdrawal
  6. Report heavy use of daily/near daily cannabis
  7. Have a urine drug screen positive for tetrahydrocannabinol (THC)/THC metabolites at Screening and Randomization
  8. Capable of giving informed consent and complying with study procedures
  9. Stated willingness to comply with all study procedures including twice weekly visits, daily evening video calls, restrictions, and availability for the duration of the study

Exclusion Criteria:

  1. Lifetime history of DSM-5 diagnosis of schizophrenia or schizoaffective disorder, or Bipolar 1 within the previous 2 years
  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 substance use disorder other than cannabis, nicotine, or caffeine use disorders
  4. Participants using cannabis for a medical condition requiring use such as epilepsy
  5. Clinically significant unstable medical disorders
  6. Any clinically important abnormalities on Screening physical examination (PE), assessments, ECG, or laboratory tests
  7. Use of an investigational drug or biologic within 30 days or 5 times the half-life (whichever is longer) prior to the Screening Visit
  8. Pregnant or lactating female participants, or a positive urine pregnancy test
  9. COVID-19

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05494437


Contacts
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Contact: LBR Regulatory, PhD (859) 426-5035 lrosenberger@lbr-regulatory.com
Contact: PleoPharma, Inc CMO, MD (610) 937-2882 jcon@pleopharma.com

Sponsors and Collaborators
PleoPharma, Inc.
Investigators
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Study Director: Jay Constantine, MD PleoPharma, Inc.
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Responsible Party: PleoPharma, Inc.
ClinicalTrials.gov Identifier: NCT05494437    
Other Study ID Numbers: CAN-002
First Posted: August 10, 2022    Key Record Dates
Last Update Posted: August 12, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by PleoPharma, Inc.:
Cannabis Use Disorder
Marijuana Use Disorder
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Gabapentin
Nabilone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents