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

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.