Effect of PP-01 on Cannabis Withdrawal Syndrome

NCT05494437 | Completed Phase 2 FDA Drug

• 1 other identifier: CAN-002
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 18

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).

Conditions

Cannabis Withdrawal

Keywords

Cannabis Use Disorder; Marijuana Use Disorder

Outcome Measures

Primary Outcomes (1)

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

  Over 5 days

Study Arms (5)

PP-01 High Dose

EXPERIMENTAL

Oral PP-01 High Dose tapered/titrated over 34 days

Combination Product: PP-01 High Dose

PP-01 Low Dose

EXPERIMENTAL

Oral PP-01 Low Dose tapered/titrated over 34 days

Combination Product: PP-01 Low Dose

Placebo

PLACEBO COMPARATOR

Oral placebo, given daily for 34 days

Drug: Placebo

Nabilone

ACTIVE COMPARATOR

oral nabilone, tapered/titrated over 28 days

Drug: Nabilone

Gabapentin

ACTIVE COMPARATOR

oral gabapentin, tapered/titrated over 34 days

Drug: Gabapentin

Interventions

PP-01 High Dose COMBINATION_PRODUCT

Cannabinoid-1 (CB1) partial agonist / GABAergic modulator

PP-01 High Dose

PP-01 Low Dose COMBINATION_PRODUCT

CB1 partial agonist / GABAergic modulator

PP-01 Low Dose

Placebo DRUG

Placebo comparator

Placebo

Nabilone DRUG

CB1 receptor

Nabilone

Gabapentin DRUG

GABAergic modulator

Gabapentin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• PleoPharma, Inc.: lead

Study Sites (18)

Behavioral Research Specialists, LLC

Glendale, California, 91206, United States

Location

Synergy San Diego

Lemon Grove, California, 91945, United States

Location

Neuropsychiatric Research Institute

Orange, California, 92868, United States

Location

CNS Clinical Research Group

Coral Springs, Florida, 33067, United States

Location

Gulf Coast Clinical Research

Fort Myers, Florida, 33912, United States

Location

Innovative Clinical Research Inc.

Lauderhill, Florida, 33319, United States

Location

CenExel iResearch Atlanta, LLC

Decatur, Georgia, 30030, United States

Location

CenExel iResearch Savannah, LLC

Savannah, Georgia, 31405, United States

Location

Pillar Clinical Research, LLC

Chicago, Illinois, 60641, United States

Location

Otrimed Research Center

Edgewood, Kentucky, 41017, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Benchmark Research

Shreveport, Louisiana, 71101, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

North Star Medical Research

Middleburg Heights, Ohio, 44130, United States

Location

Pahl Pharmaceutical Professionals LLC

Oklahoma City, Oklahoma, 73112, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

Austin Clinical Trials

Austin, Texas, 78744, United States

Location

Cedar Clinical Research

Draper, Utah, 84020, United States

Location

MeSH Terms

Interventions

nabilone; Gabapentin

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Jay Constantine, MD

  PleoPharma, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 10, 2022
• Study Start: October 27, 2022
• Primary Completion: August 21, 2023
• Study Completion: August 21, 2023
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)