Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
234 participants
INTERVENTIONAL
2022-10-27
2023-08-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PP-01 High Dose
Oral PP-01 High Dose tapered/titrated over 34 days
PP-01 High Dose
Cannabinoid-1 (CB1) partial agonist / GABAergic modulator
PP-01 Low Dose
Oral PP-01 Low Dose tapered/titrated over 34 days
PP-01 Low Dose
CB1 partial agonist / GABAergic modulator
Placebo
Oral placebo, given daily for 34 days
Placebo
Placebo comparator
Nabilone
oral nabilone, tapered/titrated over 28 days
Nabilone
CB1 receptor
Gabapentin
oral gabapentin, tapered/titrated over 34 days
Gabapentin
GABAergic modulator
Interventions
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PP-01 High Dose
Cannabinoid-1 (CB1) partial agonist / GABAergic modulator
PP-01 Low Dose
CB1 partial agonist / GABAergic modulator
Placebo
Placebo comparator
Nabilone
CB1 receptor
Gabapentin
GABAergic modulator
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
55 Years
ALL
No
Sponsors
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PleoPharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jay Constantine, MD
Role: STUDY_DIRECTOR
PleoPharma, Inc.
Locations
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Behavioral Research Specialists, LLC
Glendale, California, United States
Synergy San Diego
Lemon Grove, California, United States
Neuropsychiatric Research Institute
Orange, California, United States
CNS Clinical Research Group
Coral Springs, Florida, United States
Gulf Coast Clinical Research
Fort Myers, Florida, United States
Innovative Clinical Research Inc.
Lauderhill, Florida, United States
CenExel iResearch Atlanta, LLC
Decatur, Georgia, United States
CenExel iResearch Savannah, LLC
Savannah, Georgia, United States
Pillar Clinical Research, LLC
Chicago, Illinois, United States
Otrimed Research Center
Edgewood, Kentucky, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Benchmark Research
Shreveport, Louisiana, United States
Hassman Research Institute
Berlin, New Jersey, United States
North Star Medical Research
Middleburg Heights, Ohio, United States
Pahl Pharmaceutical Professionals LLC
Oklahoma City, Oklahoma, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Austin Clinical Trials
Austin, Texas, United States
Cedar Clinical Research
Draper, Utah, United States
Countries
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Other Identifiers
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CAN-002
Identifier Type: -
Identifier Source: org_study_id
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