Health TrialsbyHealthPanel

Efficacy of PP-01 in Mitigating Cannabis Withdrawal Symptoms in Adults With Cannabis Use Disorder

ConditionCannabis Withdrawal
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-55
SponsorPleoPharma, Inc.

About this trial

This study is a randomized, double-blind, placebo and active-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). Study participants will receive PP-01, nabilone, or placebo every day for 34 days. The total study duration will be approximately 78 days, including screening and a one-week inpatient stay. Following the initial inpatient portion of the study, participants will return to the clinic for six clinic visits and complete two telemedicine appointments. Participants will complete daily symptom diaries and other study-related questionnaires.

Participants who complete the core study may be eligible to participate in a repeat dosing extension study if they meet required criteria.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Generally healthy adults between the ages of 18 and 55, inclusive.

Meet 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.

Female participants must not be pregnant or lactating. If of childbearing potential - the participant agrees to use an accepted contraceptive regimen.

Disqualifiers

Lifetime history of DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder.

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 history of or current drug use disorder within the previous 2 years, other than cannabis, nicotine, or caffeine use disorders.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PP-01

    Combination product

    Cannabinoid-1 (CB1) partial agonist / GABAergic modulator

  • Nabilone

    Drug

    CB1 partial agonist

  • Placebo

    Drug

    Placebo comparator

Treatment groups

420 Participants
are divided into 3 treatment groups
Group A: PP-01Experimental treatment 1 intervention
Group B: NabiloneActive comparator 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

AUCs of the CSCW over Days 2 to 7, inclusive, comparing PP-01 vs Placebo

Time frame
Days to 2 to 7
2

AUCs of the CSCW over Days 25 to 35, inclusive, comparing PP-01 vs Nabilone to assess rebound

Time frame
Days 25 to 35

Secondary outcomes

1

AUCs of CWS-20 Irritability Domain scores over Days 2 to 35 comparing PP-01 vs Placebo

Time frame
Days 2 to 35
2

AUCs of CWS-20 Irritability Domain scores over Days 25 to 35 comparing PP-01 vs Nabilone

Time frame
Days 25 to 35
3

AUCs of the CSCW over Days 2 to 35 comparing PP-01 vs Placebo

Time frame
Days 2 to 35
4

AUCs of CWS-20 Sleep Domain scores over Days 2 to 35 comparing PP-01 vs Placebo

Time frame
Days 2 to 35

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PleoPharma, Inc.

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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