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CBD

Phase 2

Opiate Addiction | Small molecule | Other |Jazz Pharmaceuticals plc|Last Updated: Sep 1, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02539823Acute and Short-term Effects of CBD on Cue-induced Craving in Drug-abstinent Heroin-dependent HumansPHASE2 COMPLETED 45Sep 1, 2015May 24, 2017Sep 1, 20221 United States
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Study Endpoints
Primary Endpoints
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue (30 Minutes), and From Test Day 1 Through Test Day 4 (1 Week)) - Via the Visual Analog Scale for Craving (VASC)
VASC: test day I, II and IV - at arrival, baseline for cue 1 and 2, post-cue 1 and 2, before discharge (approximately 2.5 hours from session start on average); test day III: at arrival and discharge (approx. 2.5 hours from session start on average)

The VASC will be administered to assess potential variations in the subjective craving effects associated with heroin. Following the administration of the investigational drug, craving induced in response to the cue sessions in the clinic will be measured. Note, cue sessions occur consecutively in the same test day. In this way, changes in craving from baseline (pre-cue to post-cue within each test day), as well as changes in cue-induced craving over the short-term (test day 1 through test day 4 a week later) will be monitored and measured. VASC scale ranges from 0 for "Not Craving at All" to 10 for "Extremely Craving."

Changes in Out-of-Clinic Craving (From Pre-dose to Approximately 4-6 Hours Post-dose; and From Test Day 1 to Test Day 4 or 1 Week) - Via the Heroin Craving Questionnaire (HCQ)
HCQ: once in clinic pre-dose at each test day, and once at home after each test day.

Subjects will be asked to complete the short version of the HCQ on their own time at home and bring it with them when they return for their next visit. Upon arrival to the clinic, subjects will also complete an HCQ with the coordinator to assess daily baseline cravings. This questionnaire will help us assess changes in craving generated outside of the clinical laboratory session from test day 1 through test day 4 (1 week later). Each item is scored on a scale ranging from 1 for "Strongly Disagree" to 7 for "Strongly Agree." Sum of all 14 items are scored and added. Mean scores reported below. Total Score Range: 14 (less cravings) - 98 (more cravings).

Secondary Endpoints
Vital Signs
Pre-placebo/drug, -60 min pre-cue, -40 min pre-cue, -20 min pre-cue, cue (time 0), 15 min post-cue, 35 min post-cue, 50 min post-cue, 65 min post-cue, 85 min post-cue
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ControlPLACEBO_COMPARATORSubjects will receive a solution that resemble the Cannabidiol solution but do not have have its properties
CBD 400mgEXPERIMENTALSubjects will receive 400mg of cannabidiol
CBD 800mgEXPERIMENTALSubjects will receive 800 mg of cannabidiol
Interventions
NameTypeDescription
CBD 400 mgDRUGSubjects in Arm CBD 400 mg will receive 400mg of Cannabidiol in each of the three test sessions
CBD 800 mgDRUGSubjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions
Control (placebo)DRUGSubjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study
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Eligibility Criteria
Age Range21 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Must be between 21 and 65 years old * Must have an opiate dependence that meets criteria set in the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-V) Structured Clinical Interview for DSM (SCID-V) over the last three months * No op...

Countries:United States
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