Effect of PP-01 on Cannabis Withdrawal Syndrome
ClinicalTrials.gov ID NCT05494437 · 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
At a glance
- Status
- Completed
- Condition
- Cannabis Withdrawal
- Phase
- Phase 2
- Ages
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Not accepted
- What is being studied
- PP-01 High Dose (combination product); PP-01 Low Dose (combination product); Placebo (drug); Nabilone (drug); Gabapentin (drug)
- Sponsor
- PleoPharma, Inc.
- Target enrollment
- 234 participants
- Study sites
- 18 open in California, Florida, Georgia, Illinois, Kentucky, Louisiana, New Jersey, Ohio, Oklahoma, South Carolina, Texas, Utah
- Start date
- 2022-10-27
- Primary completion
- 2023-08-21
Common questions
Is NCT05494437 still recruiting?
ClinicalTrials.gov lists this trial as completed (checked 5 October 2026). It has 18 open or upcoming sites.
Who can take part in NCT05494437?
The record lists people aged 18 to 55 years with cannabis withdrawal. The study team decides who is eligible, and the full criteria are on this page and in the official record.
Where is NCT05494437 running?
18 sites in California, Florida, Georgia, Illinois, Kentucky, Louisiana, New Jersey, Ohio, Oklahoma, South Carolina, Texas, Utah, according to ClinicalTrials.gov.
What is being studied in NCT05494437?
It is a Phase 2 trial. The record lists these interventions: PP-01 High Dose, PP-01 Low Dose, Placebo, Nabilone and Gabapentin. The sponsor is PleoPharma, Inc.
How many people will NCT05494437 enroll?
The record gives a target of 234 participants.
How do I sign up for NCT05494437?
Contact the study team listed in the official ClinicalTrials.gov record.
About this trial
From the ClinicalTrials.gov record.
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).
Where it's running
| Site | City | State | Status |
|---|---|---|---|
| Behavioral Research Specialists, LLC | Glendale | California | Listed |
| Synergy San Diego | Lemon Grove | California | Listed |
| Neuropsychiatric Research Institute | Orange | California | Listed |
| CNS Clinical Research Group | Coral Springs | Florida | Listed |
| Gulf Coast Clinical Research | Fort Myers | Florida | Listed |
| Innovative Clinical Research Inc. | Lauderhill | Florida | Listed |
| CenExel iResearch Atlanta, LLC | Decatur | Georgia | Listed |
| CenExel iResearch Savannah, LLC | Savannah | Georgia | Listed |
| Pillar Clinical Research, LLC | Chicago | Illinois | Listed |
| Otrimed Research Center | Edgewood | Kentucky | Listed |
| Tandem Clinical Research | Marrero | Louisiana | Listed |
| Benchmark Research | Shreveport | Louisiana | Listed |
| Hassman Research Institute | Berlin | New Jersey | Listed |
| North Star Medical Research | Middleburg Heights | Ohio | Listed |
| Pahl Pharmaceutical Professionals LLC | Oklahoma City | Oklahoma | Listed |
| Medical University of South Carolina | Charleston | South Carolina | Listed |
| Austin Clinical Trials | Austin | Texas | Listed |
| Cedar Clinical Research | Draper | Utah | Listed |
Full eligibility criteria (from the record)
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
This listing shows only what the public ClinicalTrials.gov record NCT05494437 says, last updated there on 2024-08-16. It was checked against the registry on 5 October 2026. Taking part is voluntary, and the study team decides who is eligible. For the most current details, see the official record.
