Clinical trial NCT05494437: Effect of PP-01 on Cannabis Withdrawal Syndrome
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Multiple-Dose, Placebo Controlled Clinical Trial of Two Doses of PP-01 for the Mitigation of Cannabis Withdrawal Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cannabis Withdrawal
Keywords: Cannabis Use Disorder
Marijuana Use Disorder
Lead sponsor: PleoPharma, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-10
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of a patient reported outcome measure of cannabis withdrawal over 5 days
timeFrame: Over 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: Lemon Grove
country: United States
facility: Synergy San Diego
state: California
city: Orange
country: United States
facility: Neuropsychiatric Research Institute
state: California
city: Coral Springs
country: United States
facility: CNS Clinical Research Group
state: Florida
city: Fort Myers
country: United States
facility: Gulf Coast Clinical Research
state: Florida
city: Lauderhill
country: United States
facility: Innovative Clinical Research Inc.
state: Florida
city: Decatur
country: United States
facility: CenExel iResearch Atlanta, LLC
state: Georgia
city: Savannah
country: United States
facility: CenExel iResearch Savannah, LLC
state: Georgia
city: Chicago
country: United States
facility: Pillar Clinical Research, LLC
state: Illinois
city: Edgewood
country: United States
facility: Otrimed Research Center
state: Kentucky
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Shreveport
country: United States
facility: Benchmark Research
state: Louisiana
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Middleburg Heights
country: United States
facility: North Star Medical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Pahl Pharmaceutical Professionals LLC
state: Oklahoma
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: Austin Clinical Trials
state: Texas
city: Draper
country: United States
facility: Cedar Clinical Research
state: Utah
Study officials:
affiliation: PleoPharma, Inc.
name: Jay Constantine, MD
role: STUDY_DIRECTOR
References: