Cannabis WithdrawalPhase 2NCT05494437
Effect of PP-01 on Cannabis Withdrawal Syndrome
A Phase 2 study testing PP-01 High Dose, PP-01 Low Dose and Nabilone in people with Cannabis Withdrawal, run by PleoPharma, Inc. at 18 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cannabis Withdrawal
- What is being tested?
- PP-01 High Dose, PP-01 Low Dose and Nabilone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 18 sitesUnited States
- Study dates
- 27 Oct 2022to 21 Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Austin Clinical Trials
Austin, Texas, 78744
Hassman Research Institute
Berlin, New Jersey, 08009
Medical University of South Carolina
Charleston, South Carolina, 29403
Pillar Clinical Research, LLC
Chicago, Illinois, 60641
CNS Clinical Research Group
Coral Springs, Florida, 33067
CenExel iResearch Atlanta, LLC
Decatur, Georgia, 30030
Cedar Clinical Research
Draper, Utah, 84020
Otrimed Research Center
Edgewood, Kentucky, 41017
Gulf Coast Clinical Research
Fort Myers, Florida, 33912
Behavioral Research Specialists, LLC
Glendale, California, 91206
Innovative Clinical Research Inc.
Lauderhill, Florida, 33319
Synergy San Diego
Lemon Grove, California, 91945
Tandem Clinical Research
Marrero, Louisiana, 70072
North Star Medical Research
Middleburg Heights, Ohio, 44130
Pahl Pharmaceutical Professionals LLC
Oklahoma City, Oklahoma, 73112
Neuropsychiatric Research Institute
Orange, California, 92868
CenExel iResearch Savannah, LLC
Savannah, Georgia, 31405
Benchmark Research
Shreveport, Louisiana, 71101
About this study
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
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).
- Conditions
- Cannabis Withdrawal
- Being tested
- PP-01 High Dose, PP-01 Low Dose, Placebo, Nabilone, Gabapentin
- Keywords
- Cannabis Use Disorder, Marijuana Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PP-01 High DoseCombination product
Cannabinoid-1 (CB1) partial agonist / GABAergic modulator
PP-01 Low DoseCombination product
CB1 partial agonist / GABAergic modulator
PlaceboDrug
Placebo comparator
NabiloneDrug
CB1 receptor
GabapentinDrug
GABAergic modulator
| Study group | Role | What they receive |
|---|---|---|
| PP-01 High Dose | Experimental | Oral PP-01 High Dose tapered/titrated over 34 days Receives: Combination Product: PP-01 High Dose |
| PP-01 Low Dose | Experimental | Oral PP-01 Low Dose tapered/titrated over 34 days Receives: Combination Product: PP-01 Low Dose |
| Placebo | Placebo comparator | Oral placebo, given daily for 34 days Receives: Drug: Placebo |
| Nabilone | Active comparator | oral nabilone, tapered/titrated over 28 days Receives: Drug: Nabilone |
| Gabapentin | Active comparator | oral gabapentin, tapered/titrated over 34 days Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of a patient reported outcome measure of cannabis withdrawal over 5 days
Measured: Over 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start27 Oct 2022
- Primary completion21 Aug 2023
- Study completion21 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis WithdrawalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- PleoPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jay Constantine, MD, Study director, PleoPharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494437
- Sponsor's protocol ID
- CAN-002
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2022
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05494437
- Acronym / sponsor ID
- CAN-002
- Conditions
- Cannabis Withdrawal
- Keywords
- Cannabis Use Disorder, Marijuana Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- PleoPharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 21 Aug 2023 (actual)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PP-01 High Dose | Experimental | Combination Product: PP-01 High DoseOral PP-01 High Dose tapered/titrated over 34 days |
| PP-01 Low Dose | Experimental | Combination Product: PP-01 Low DoseOral PP-01 Low Dose tapered/titrated over 34 days |
| Placebo | Placebo comparator | Drug: PlaceboOral placebo, given daily for 34 days |
| Nabilone | Active comparator | Drug: Nabiloneoral nabilone, tapered/titrated over 28 days |
| Gabapentin | Active comparator | Drug: Gabapentinoral gabapentin, tapered/titrated over 34 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PP-01 High DoseCannabinoid-1 (CB1) partial agonist / GABAergic modulator | Combination product | PP-01 High Dose |
| PP-01 Low DoseCB1 partial agonist / GABAergic modulator | Combination product | PP-01 Low Dose |
| PlaceboPlacebo comparator | Drug | Placebo |
| NabiloneCB1 receptor | Drug | Nabilone |
| GabapentinGABAergic modulator | Drug | Gabapentin |
Primary outcome
Evaluation of a patient reported outcome measure of cannabis withdrawal over 5 days
Time frame: Over 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Cannabis Withdrawal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Constantine, MD study director
PleoPharma, Inc.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PP-01 High Dose, PP-01 Low Dose and Nabilone in people with Cannabis Withdrawal, run by PleoPharma, Inc. at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of a patient reported outcome measure of cannabis withdrawal over 5 days (time frame: Over 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.