Effect of PP-01 on Cannabis Withdrawal Syndrome

• Sponsor: PleoPharma, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05494437
• Collaborator: (none)
• Enrollment: 225
• Arms: 5
• Anticipated Duration (Months): 13

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cannabis Withdrawal	Combination Product: PP-01 High Dose; Combination Product: PP-01 Low Dose; Drug: Placebo; Drug: Nabilone; Drug: Gabapentin	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 225 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PP-01 High Dose Oral PP-01 High Dose tapered/titrated over 34 days	Combination Product: PP-01 High Dose; Cannabinoid-1 (CB1) partial agonist / GABAergic modulator
Experimental: PP-01 Low Dose Oral PP-01 Low Dose tapered/titrated over 34 days	Combination Product: PP-01 Low Dose; CB1 partial agonist / GABAergic modulator
Placebo Comparator: Placebo Oral placebo, given daily for 34 days	Drug: Placebo; Placebo comparator
Active Comparator: Nabilone oral nabilone, tapered/titrated over 28 days	Drug: Nabilone; CB1 receptor
Active Comparator: Gabapentin oral gabapentin, tapered/titrated over 34 days	Drug: Gabapentin; GABAergic modulator

Outcome Measures

Primary Outcome Measures

1. Evaluation of a patient reported outcome measure of cannabis withdrawal over 5 days [Over 5 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• PleoPharma, Inc.

Investigators

• Study Director: Jay Constantine, MD, PleoPharma, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: PleoPharma, Inc.
• ClinicalTrials.gov Identifier: NCT05494437
• Other Study ID Numbers: CAN-002
• First Posted: Aug 10, 2022
• Last Update Posted: Aug 12, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by PleoPharma, Inc.: Cannabis Use Disorder; Marijuana Use Disorder
• Additional relevant MeSH terms: Marijuana Abuse; Gabapentin; Nabilone

Study Results

No Results Posted as of Aug 12, 2022