NCT07644052
Efficacy of PP-01 in Mitigating Cannabis Withdrawal Symptoms in Adults With Cannabis Use Disorder
Recruiting
PHASE3Ages 18–55InterventionalTreatmentPleoPharma, Inc.
~420 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:PP-01NabilonePlacebo
At a glance
Recruiting sites
21 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
AUCs of the CSCW over Days 2 to 7, inclusive, comparing PP-01 vs Placebo
Measured over Days to 2 to 7
+1 more outcome measured
Conditions
Where it's being run
21 sites across 13 statesFlorida5
Georgia3
Arkansas2
New York2
Connecticut1
Kentucky1
Maryland1
Nevada1
Study leadership
- Jay Constantine, MD · STUDY_DIRECTOR · PleoPharma, Inc.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
If of childbearing potential - the participant agrees to use one of the accepted contraceptive regimens from Screening to the first administration of the study medication, during the study, and for at least 30 days after the last dose of the study medication. An acceptable method of contraception includes one of the following:
Hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch)
Intrauterine device (with or without hormones)
OR agrees to use a double barrier method (e.g., condom and spermicide) during the study and for at least 30 days after the last dose of the study medication
The Investigator can use their judgement and familiarity with the participant's preferred and usual lifestyle to understand which form of birth control would be the best and also to determine if abstinence is an option what would achieve 100% effectiveness
Females of non-childbearing potential - should be surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or be postmenopausal (at least 1 year without menses) 5. Male participants who are fertile and engage in sexual activity must agree to use a double barrier method (e.g., condom and spermicide) and agree to not donate sperm during the study and for at least 90 days after the last dose of the study medication. 6. Be seeking and motivated to discontinue cannabis and to minimize withdrawal symptoms related to cannabis discontinuation. 7. Agree to not use cannabis or any product containing CBD, hemp derivatives, terpenes or any THC containing product including delta-8, delta-10, THC-A or any other cannabinoid-like product following Randomization and throughout the study duration. 8. Have experienced cravings for cannabis and at least three withdrawal symptoms as defined by DSM-5 Cannabis Withdrawal Syndrome diagnostic criteria within the past year when previously trying to discontinue or reduce use of cannabis 9. Meet Criterion C on the DSM-5 Cannabis Withdrawal Diagnostic Criteria 10. Participants should be self-reported heavy cannabis users ("medical marijuana" users are allowed) who report use of cannabis multiple times per day at least 6 days per week for at least 6 months:
Exclusion
Central lab: Serum creatinine \> 1.30 mg/dL for females or \> 1.52 mg/dL for males
Non-central lab: Serum creatinine \> 30% above the ULN for the laboratory used 3. Serum bilirubin \> 1.5 times ULN, unless documented Gilbert's Disease; AST or ALT \> 1.5 times ULN 4. Clinically significant abnormal fasting glucose For criteria a, b, c, and d the test can be repeated one time during the Screening period at the discretion of the Investigator. If this option is used the last obtained reading will be used for determination of eligibility. Averages will not be used. 5. Hypertension at Screening or Randomization; participants with elevated sitting BP, defined as greater than 145 mmHg systolic or greater than 95 mmHg diastolic
Corrected QT interval using Fridericia's formula \> 450 msec for males and \> 470 msec for females at Randomization, mean values are allowed to be assessed 12. Known history of allergy, intolerance, or hypersensitivity to nabilone, gabapentin or pregabalin. 13. Prohibited medications at Screening:
Current use of narcotics, opioid agonists and antagonists, kratom, illicit drugs, ketamine, or products intended to induce a feeling of being high except for cannabis
Psychedelics
Medications, including OTC products, to help with sleep or anxiety within 2 months of Screening
Current use of nabilone, dronabinol, Sativex, Epidiolex, synthetic cannabinoids
Gabapentin or pregabalin or use within 30 days of Screening
Medications listed in Section 9.3 of the study protocol (cannabis and "medical marijuana" are allowed during Screening) 14. Heavy users of alcohol (\> 2 drinks/day for men and \> 1 drink/day for women) over the past year. 15. Binge drinkers of alcohol (≥ 5 drinks for men and ≥ 4 drinks for women on the same occasion) within 30 days of Screening. 16. A positive urine drug/alcohol test at Screening or Randomization for narcotics and/or illicit drugs other than cannabis. If the test is positive for benzodiazepines or alcohol at Screening, and if it is reported that they are only occasional users, a repeat urine drug screen can be performed at the discretion of the Medical Monitor and must be negative at the time of Randomization. 17. Use of an investigational drug or biologic within 30 days or 5 times the half-life (whichever is longer) prior to the Screening Visit. 18. Suspected active influenza or COVID-19 infection. 19. Vaccinations including COVID-19:
Participants planning to have a COVID-19 vaccine during study participation
History of COVID-19 vaccine within 5 days of Screening. Participant can be rescreened after a 5-day post vaccine period 20. Prior participation in any PleoPharma clinical study.
What this trial measures
- AUCs of the CSCW over Days 2 to 7, inclusive, comparing PP-01 vs PlaceboDays to 2 to 7
- AUCs of the CSCW over Days 25 to 35, inclusive, comparing PP-01 vs Nabilone to assess reboundDays 25 to 35