Effect of PP-01 on Cannabis Withdrawal Syndrome

PleoPharma

Status and phase: Completed; Phase 2

Conditions: Cannabis Withdrawal

Treatments: Drug: Gabapentin; Combination Product: PP-01 Low Dose; Combination Product: PP-01 High Dose; Drug: Placebo; Drug: Nabilone

Study type: Interventional

Funder types: Industry

Identifiers

NCT05494437

CAN-002

Details and patient eligibility

About

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).

Enrollment: 234 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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234 participants in 5 patient groups, including a placebo group

PP-01 High Dose

Experimental group

Description:

Oral PP-01 High Dose tapered/titrated over 34 days

Treatment:

Combination Product: PP-01 High Dose

PP-01 Low Dose

Experimental group

Description:

Oral PP-01 Low Dose tapered/titrated over 34 days

Treatment:

Combination Product: PP-01 Low Dose

Placebo

Placebo Comparator group

Description:

Oral placebo, given daily for 34 days

Treatment:

Drug: Placebo

Nabilone

Active Comparator group

Description:

oral nabilone, tapered/titrated over 28 days

Treatment:

Drug: Nabilone

Gabapentin

Active Comparator group

Description:

oral gabapentin, tapered/titrated over 34 days

Treatment:

Drug: Gabapentin