Effect of PP-01 on Cannabis Withdrawal Syndrome

Cannabis Withdrawal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05494437
• Other study ID #: CAN-002
• Status: Completed
• Phase: Phase 2
• Start date: October 27, 2022
• Est. completion date: August 21, 2023

Study information

• Verified date: December 2023
• Source: PleoPharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: August 21, 2023
• Est. primary completion date: August 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis Withdrawal
• Marijuana Abuse

Intervention

Combination Product:
• PP-01 High Dose
Cannabinoid-1 (CB1) partial agonist / GABAergic modulator
• PP-01 Low Dose
CB1 partial agonist / GABAergic modulator

Drug:
• Placebo
Placebo comparator
• Nabilone
CB1 receptor
• Gabapentin
GABAergic modulator

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
PleoPharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of a patient reported outcome measure of cannabis withdrawal over 5 days		Over 5 days