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Completed

NCT Number: NCT05494437

Effect of PP-01 on Cannabis Withdrawal Syndrome

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).

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Key information

Conditions

Cannabis Withdrawal

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Behavioral Research Specialists, LLC, Glendale, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Generally healthy individuals between the ages of 18 and 55, inclusive
  • 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
  • BMI within 18.0 to 38.0 kg/m2, inclusive
  • Seeking to minimize withdrawal symptoms related to cannabis discontinuation in people seeking to discontinue cannabis
  • Meet DSM-5 Cannabis Withdrawal
  • Report heavy use of daily/near daily cannabis
  • Have a urine drug screen positive for tetrahydrocannabinol (THC)/THC metabolites at Screening and Randomization
  • Capable of giving informed consent and complying with study procedures
  • 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

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

Treatment and study plan

PP-01 High Dose

Combination Product

Cannabinoid-1 (CB1) partial agonist / GABAergic modulator

PP-01 Low Dose

Combination Product

CB1 partial agonist / GABAergic modulator

Placebo

Drug

Placebo comparator

Nabilone

Drug

CB1 receptor

Gabapentin

Drug

GABAergic modulator

Primary outcomes

  1. Evaluation of a patient reported outcome measure of cannabis withdrawal over 5 days

    Time frame: Over 5 days

Sponsors and collaborators

Lead sponsor

PleoPharma, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 10, 2022
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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