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CBD · 1 trial · 1 indication
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."
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).
| Arm | Type | Description |
|---|---|---|
| Control | PLACEBO_COMPARATOR | Subjects will receive a solution that resemble the Cannabidiol solution but do not have have its properties |
| CBD 400mg | EXPERIMENTAL | Subjects will receive 400mg of cannabidiol |
| CBD 800mg | EXPERIMENTAL | Subjects will receive 800 mg of cannabidiol |
| Name | Type | Description |
|---|---|---|
| CBD 400 mg | DRUG | Subjects in Arm CBD 400 mg will receive 400mg of Cannabidiol in each of the three test sessions |
| CBD 800 mg | DRUG | Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions |
| Control (placebo) | DRUG | Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study |
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...
CBD is being studied for use in opiate addiction, specifically to reduce cue-induced craving in drug-abstinent heroin-dependent individuals. It is an investigational small molecule being developed by Jazz Pharmaceuticals plc. The drug is currently in Phase 2 clinical development for this indication.
CBD targets the endocannabinoid system, though the specific molecular target is not detailed. It is being evaluated for its effects on cue-induced craving in heroin-dependent individuals. The drug's mechanism of action is believed to involve modulation of cannabinoid receptors, but this has not been explicitly confirmed in the available data.
CBD is being developed by Jazz Pharmaceuticals plc, a biopharmaceutical company traded on the NASDAQ under the ticker JAZZ. The company is conducting clinical research on CBD for the treatment of opiate addiction, with the drug currently in Phase 2 development.
CBD is in Phase 2 clinical development for opiate addiction. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the drug is not currently in active clinical trials according to the available data.
CBD has one completed clinical trial, NCT02539823, titled 'Acute and Short-term Effects of CBD on Cue-induced Craving in Drug-abstinent Heroin-dependent Humans.' This Phase 2 study enrolled 45 participants in the United States and was a randomized, double-blind, placebo-controlled trial.
CBD is the same compound as other cannabidiol products, but it is being specifically developed by Jazz Pharmaceuticals for opiate addiction. The drug is a small molecule and is distinct from other formulations in its intended use and clinical development program.