Effect of PP-01 on Cannabis Withdrawal Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Cannabis Withdrawal

In brief

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).

Key facts

Study ID

NCT05494437

Run by

PleoPharma, Inc.

People needed

234

Starts

2022-10-27

Expected to finish

2023-08-21

Last updated by the study team

2024-08-16

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Behavioral Research Specialists, LLC — Glendale, California, United States
• Synergy San Diego — Lemon Grove, California, United States
• Neuropsychiatric Research Institute — Orange, California, United States
• CNS Clinical Research Group — Coral Springs, Florida, United States
• Gulf Coast Clinical Research — Fort Myers, Florida, United States
• Innovative Clinical Research Inc. — Lauderhill, Florida, United States
• CenExel iResearch Atlanta, LLC — Decatur, Georgia, United States
• CenExel iResearch Savannah, LLC — Savannah, Georgia, United States
• Pillar Clinical Research, LLC — Chicago, Illinois, United States
• Otrimed Research Center — Edgewood, Kentucky, United States
• Tandem Clinical Research — Marrero, Louisiana, United States
• Benchmark Research — Shreveport, Louisiana, United States
• Hassman Research Institute — Berlin, New Jersey, United States
• North Star Medical Research — Middleburg Heights, Ohio, United States
• Pahl Pharmaceutical Professionals LLC — Oklahoma City, Oklahoma, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Austin Clinical Trials — Austin, Texas, United States
• Cedar Clinical Research — Draper, Utah, United States

Full record on ClinicalTrials.gov

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