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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

More Details

Status
Completed
Sponsor
PleoPharma, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.