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New pill aims to take the edge off quitting weed

NCT ID NCT07644052

Symptom relief Sponsor: PleoPharma, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 15 times

Summary

This study tests a new medication called PP-01 to help adults with cannabis use disorder manage withdrawal symptoms when they stop using cannabis. About 420 participants will receive PP-01, an existing drug (nabilone), or a placebo daily for 34 days, with a one-week hospital stay at the start. The goal is to see if PP-01 reduces symptoms like irritability and sleep trouble better than placebo or nabilone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PP-01 (a combination product that partially activates cannabinoid receptors and modulates GABA)
What this could lead to
If successful, this could provide a new medication to help people quit cannabis by reducing withdrawal symptoms like irritability and sleep problems.
What could go wrong
This is a Phase 3 trial, but it's still experimental. The drug may not work better than placebo or existing treatments, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 420 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Generally healthy adults between the ages of 18 and 55, inclusive. 2. Meet 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. Female participants must not be pregnant or lactating. If of childbearing potential - the participant agrees to use an accepted contraceptive regimen. 5. Male participants who are fertile and engage in sexual activity must agree to use a double barrier method (e.g., condom and spermicide) during the study and to not donate sperm for 90 days after the last dose of study medication. 6. Be seeking and motivated to discontinue cannabis and to minimize withdrawal symptoms. 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. Meet DSM-5 Cannabis Withdrawal Criteria. 9. Report heavy use of daily/near daily cannabis. 10. Have a urine drug screen positive for THC/THC metabolite and have a negative result for all other illicit/excluded drugs and alcohol at Screening and Randomization. 11. Capable of giving informed consent and stated willingness to comply with all study procedures including inpatient and weekly outpatient visits, daily evening video calls, restrictions, and availability for the duration of the study. 12. Willing to be admitted to an inpatient clinic with overnight stays on Days 1 through 6 and return for all outpatient visits. 13. Ability to take study drug capsules at approximately the same time each day. 14. Have regular access to the internet and access to video/virtual capabilities for video calls by any means. 15. Agree to not use any alcohol during the study. 16. No plan to change current nicotine use. 17. Ability to read, understand, and complete daily diaries. Exclusion Criteria: 1. Lifetime history of DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder. 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 history of or current drug use disorder within the previous 2 years, other than cannabis, nicotine, or caffeine use disorders. 4. Participants who consume alcohol on a regular or frequent basis and who do not agree or are deemed by the Investigator to be unable to discontinue alcohol for the duration of the study. 5. Participants using cannabis for a physician directed medical condition requiring use such as epilepsy. 6. Any clinically important abnormalities on Screening physical examination, assessments, electrocardiogram, or laboratory tests. 7. Current or recent history of significant violent or suicidal behavior, risk for suicide or homicide. 8. History of clinically significant medical condition that, in the opinion of the Principal Investigator, would jeopardize the safety of the participant or impact on the validity of the study results. 9. Participants with risk factors for seizure. 10. Known history of allergy, intolerance, or hypersensitivity to nabilone, gabapentin, or pregabalin. 11. Prohibited medications at Screening: * Current use of narcotics, psychedelics, stimulants, opioid agonists and antagonists, kratom, illicit drugs, ketamine, unregulated psychoactive drugs (sometimes known as "gas station drugs"), or products intended to induce a feeling of being high except for cannabis * Regular benzodiazepine use (more than once per week) and no use within 7 days of Baseline Visit (Day 1) * Current use (within 7 days of Baseline Visit) of OTC products to help with sleep or anxiety * Prescription medications to help with sleep or anxiety within 14 days of Screening * Current use of nabilone, dronabinol, Sativex, Epidiolex, synthetic cannabinoids * Gabapentin or pregabalin or use within 30 days of Screening 12. Heavy users of alcohol within 60 days of Screening or binge drinkers of alcohol within 30 days of Screening. 13. 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. 14. Use of an investigational drug or biologic within 30 days or 5 times the half-life (whichever is longer) prior to the Screening Visit. 15. Active influenza or COVID-19 infection or planned vaccination. 16. Prior participation in any PleoPharma clinical study.

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Conditions

The condition(s) this trial relates to.

cannabis dependence substance withdrawal syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cannabis withdrawal

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AMR Clinical

    RECRUITING

    Lexington, Kentucky, 40509, United States

  • AMR Clinical

    RECRUITING

    Knoxville, Tennessee, 37920, United States

  • CenExel iResearch, LLC

    RECRUITING

    Savannah, Georgia, 31405, United States

  • Coastal Carolina Research Center, LLC

    RECRUITING

    North Charleston, South Carolina, 29405, United States

  • Community Clinical Research, Inc.

    RECRUITING

    Austin, Texas, 78754, United States

  • Evergreen Clinical Trials

    RECRUITING

    Norcross, Georgia, 30092, United States

  • ForCare Clinical Research

    RECRUITING

    Tampa, Florida, 33613, United States

  • Hassman Research Institute, LLC d/b/a CenExel Marlton, NJ

    RECRUITING

    Marlton, New Jersey, 08053, United States

  • Maryland Psychiatric Research Center, University of Maryland School of Medicine

    RECRUITING

    Baltimore, Maryland, 21228, United States

  • Memorial Hermann Village

    RECRUITING

    Houston, Texas, 77043, United States

  • Neuro-Behavioral Clinical Research, Inc.

    RECRUITING

    North Canton, Ohio, 44720, United States

  • Neuroscience Research Institute

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • Oasis Clinical Research

    RECRUITING

    Las Vegas, Nevada, 89121, United States

  • Research Centers of America

    RECRUITING

    Hollywood, Florida, 33024, United States

  • Richmond Behavioral Associates

    RECRUITING

    Staten Island, New York, 10314, United States

  • Sandhill Research, LLC d/b/a Accel Research Sites - NeuroStudies Clinical Research Unit 755

    RECRUITING

    Decatur, Georgia, 30030, United States

  • Sandhill Research, LLC d/b/a Accel Research Sites - St. Pete - Largo Clinical Research Unit

    RECRUITING

    Largo, Florida, 33777, United States

  • The Research Foundation for Mental Hygiene/ New York State Psychiatric Institute

    RECRUITING

    New York, New York, 10032, United States

  • University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - DeLand Clinical Research Unit

    RECRUITING

    DeLand, Florida, 32720, United States

  • Woodland International Research Group, LLC

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Woodland Research Northwest, LLC

    RECRUITING

    Rogers, Arkansas, 72758, United States

  • Yale Stress Center

    RECRUITING

    New Haven, Connecticut, 06519, United States

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