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Effect of PP-01 on Cannabis Withdrawal Syndrome

Primary Purpose

Cannabis Withdrawal

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PP-01 High Dose
PP-01 Low Dose
Placebo
Nabilone
Gabapentin
Sponsored by
PleoPharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Withdrawal focused on measuring Cannabis Use Disorder, Marijuana Use Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Behavioral Research Specialists, LLC
  • Synergy San Diego
  • Neuropsychiatric Research Institute
  • CNS Clinical Research Group
  • Gulf Coast Clinical Research
  • Innovative Clinical Research Inc.
  • CenExel iResearch Atlanta, LLC
  • CenExel iResearch Savannah, LLC
  • Pillar Clinical Research, LLC
  • Otrimed Research Center
  • Tandem Clinical Research
  • Benchmark Research
  • Hassman Research Institute
  • North Star Medical Research
  • Pahl Pharmaceutical Professionals LLC
  • Medical University of South Carolina
  • Austin Clinical Trials
  • Cedar Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

PP-01 High Dose

PP-01 Low Dose

Placebo

Nabilone

Gabapentin

Arm Description

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

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

Oral placebo, given daily for 34 days

oral nabilone, tapered/titrated over 28 days

oral gabapentin, tapered/titrated over 34 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 8, 2022
Last Updated
June 23, 2023
Sponsor
PleoPharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05494437
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 27, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PleoPharma, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Withdrawal
Keywords
Cannabis Use Disorder, Marijuana Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PP-01 High Dose
Arm Type
Experimental
Arm Description
Oral PP-01 High Dose tapered/titrated over 34 days
Arm Title
PP-01 Low Dose
Arm Type
Experimental
Arm Description
Oral PP-01 Low Dose tapered/titrated over 34 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral placebo, given daily for 34 days
Arm Title
Nabilone
Arm Type
Active Comparator
Arm Description
oral nabilone, tapered/titrated over 28 days
Arm Title
Gabapentin
Arm Type
Active Comparator
Arm Description
oral gabapentin, tapered/titrated over 34 days
Intervention Type
Combination Product
Intervention Name(s)
PP-01 High Dose
Intervention Description
Cannabinoid-1 (CB1) partial agonist / GABAergic modulator
Intervention Type
Combination Product
Intervention Name(s)
PP-01 Low Dose
Intervention Description
CB1 partial agonist / GABAergic modulator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator
Intervention Type
Drug
Intervention Name(s)
Nabilone
Intervention Description
CB1 receptor
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
GABAergic modulator
Primary Outcome Measure Information:
Title
Evaluation of a patient reported outcome measure of cannabis withdrawal over 5 days
Time Frame
Over 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Constantine, MD
Organizational Affiliation
PleoPharma, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Behavioral Research Specialists, LLC
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Synergy San Diego
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
Neuropsychiatric Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
CNS Clinical Research Group
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Gulf Coast Clinical Research
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Innovative Clinical Research Inc.
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
CenExel iResearch Atlanta, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
CenExel iResearch Savannah, LLC
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Pillar Clinical Research, LLC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60641
Country
United States
Facility Name
Otrimed Research Center
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Benchmark Research
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
North Star Medical Research
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Pahl Pharmaceutical Professionals LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Austin Clinical Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States
Facility Name
Cedar Clinical Research
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of PP-01 on Cannabis Withdrawal Syndrome

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