Effect of PP-01 on Cannabis Withdrawal Syndrome

Phase 2

Completed

• Conditions: Cannabis Withdrawal
• Interventions: Combination Product: PP-01 High Dose; Combination Product: PP-01 Low Dose; Drug: Placebo; Drug: Nabilone; Drug: Gabapentin

• Registration Number: NCT05494437
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-08
• Study First Posted: 2022-08-10
• Study Start: 2022-10-27
• Primary Completion: 2023-08-21
• Study Completion: 2023-08-21
• Disposition First Posted: 2023-12-06
• Status Verified: 2024-08
• Disposition First Submitted: 2024-08-14
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PP-01 High Dose	PP-01 High Dose	Oral PP-01 High Dose tapered/titrated over 34 days
PP-01 Low Dose	PP-01 Low Dose	Oral PP-01 Low Dose tapered/titrated over 34 days
Placebo	Placebo	Oral placebo, given daily for 34 days
Nabilone	Nabilone	oral nabilone, tapered/titrated over 28 days
Gabapentin	Gabapentin	oral gabapentin, tapered/titrated over 34 days

Primary Outcome Measures

Name	Time	Method
Evaluation of a patient reported outcome measure of cannabis withdrawal over 5 days	Over 5 days

Trial Locations

Locations (18)

Pahl Pharmaceutical Professionals LLC; 🇺🇸 Oklahoma City, Oklahoma, United States

Pillar Clinical Research, LLC; 🇺🇸 Chicago, Illinois, United States

Behavioral Research Specialists, LLC; 🇺🇸 Glendale, 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

Synergy San Diego; 🇺🇸 Lemon Grove, California, 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

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

Cedar Clinical Research; 🇺🇸 Draper, Utah, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Austin Clinical Trials; 🇺🇸 Austin, Texas, United States