Effect of PP-01 on Cannabis Withdrawal Syndrome
Public ClinicalTrials.gov record NCT05494437. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT05494437
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 234 participants
Conditions and interventions
Conditions
Interventions
- PP-01 High Dose Combination Product
- PP-01 Low Dose Combination Product
- Placebo Drug
- Nabilone Drug
- Gabapentin Drug
Combination Product · Drug
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 27, 2022 (Actual)
- Primary completion
- Aug 21, 2023 (Actual)
- Completion
- Aug 21, 2023 (Actual)
- Last update posted
- Aug 16, 2024
2022 – 2023
United States locations
- U.S. sites
- 18
- U.S. states
- 12
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Behavioral Research Specialists, LLC | Glendale | California | 91206 | — |
| Synergy San Diego | Lemon Grove | California | 91945 | — |
| Neuropsychiatric Research Institute | Orange | California | 92868 | — |
| CNS Clinical Research Group | Coral Springs | Florida | 33067 | — |
| Gulf Coast Clinical Research | Fort Myers | Florida | 33912 | — |
| Innovative Clinical Research Inc. | Lauderhill | Florida | 33319 | — |
| CenExel iResearch Atlanta, LLC | Decatur | Georgia | 30030 | — |
| CenExel iResearch Savannah, LLC | Savannah | Georgia | 31405 | — |
| Pillar Clinical Research, LLC | Chicago | Illinois | 60641 | — |
| Otrimed Research Center | Edgewood | Kentucky | 41017 | — |
| Tandem Clinical Research | Marrero | Louisiana | 70072 | — |
| Benchmark Research | Shreveport | Louisiana | 71101 | — |
| Hassman Research Institute | Berlin | New Jersey | 08009 | — |
| North Star Medical Research | Middleburg Heights | Ohio | 44130 | — |
| Pahl Pharmaceutical Professionals LLC | Oklahoma City | Oklahoma | 73112 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29403 | — |
| Austin Clinical Trials | Austin | Texas | 78744 | — |
| Cedar Clinical Research | Draper | Utah | 84020 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05494437, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 16, 2024 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05494437 live on ClinicalTrials.gov.