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Dronabinol

Phase 1

Drug Abuse, Medication | Small molecule | Other |cbdMD, Inc.|Last Updated: May 13, 2014

Success Probability

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Market & Valuation

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Trial Design

Double-BlindUNCONTROLLED
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

Clinical trial landscape

Dronabinol · 1 trial · 1 indication

Phase 1 1
NCT02094599A Study of the Abuse Potential of Dronabinol in Recreational Cannabinoid UsersDrug Abuse, Medication
COMPLETED43 Analytics
PHASE1COMPLETED
A Study of the Abuse Potential of Dronabinol in Recreational Cannabinoid Users
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Study Endpoints

Primary Endpoints

Peak score (Emax) on Drug Liking calculated from a 100-point visual analogue scale (VAS), where 0=strong disliking and 100=strong liking
within 24 hours post-dose

Secondary Endpoints

Peak score (Emax) for Drug Effects, calculated from scores on a VAS scale of 0-100, where 0=not at all and 100=extremely
within 24 hours post-dose
Peak score (Emax) for a shortened Addiction Research Center Inventory (ARCI) scale of 0-49, where 49 is the highest possible score
within 24 hours post-dose
Peak score (Emax) for Subjective Drug Value (SDV) in dollars
within 24 hours post-dose
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Study Design & Arms

AllocationNA
MaskingTRIPLE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
All Enrolled ParticipantsEXPERIMENTALEach participant receives all treatments (of placebo, dronabinol 10 mg and dronabinol 30 mg) in a 5-way crossover design. At each treatment visit, participants receive a single dose, contained in two syringes of oral solution and three capsules. When dronabinol is in syringes, placebo is in capsules, and when dronabinol is in capsules, placebo is in syringes. When assigned to take placebo only, placebo is in both the syringes and the capsules.

Interventions

NameTypeDescription
Dronabinol 10 mgDRUGDronabinol at a strength equivalent to 10 mg provided in capsules or as an oral solution in syringes.
Dronabinol 30 mgDRUGDronabinol at a strength equivalent to 30 mg provided in capsules or as an oral solution in syringes.
PlaceboDRUGMatching placebo provided in capsules or as an oral solution in syringes.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy adult protocol-defined recreational cannabinoid user * Meets protocol-specified criteria for qualification and contraception * Able to speak, read and understand English well enough to understand the nature of the study, provide written informed consent, and to allow c...

Countries:Canada
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Frequently asked questions about Dronabinol

What is Dronabinol used for?

Dronabinol is being studied for use in drug abuse and medication-related conditions. It is an investigational small molecule currently in clinical development, with a completed Phase 1 trial evaluating its abuse potential in recreational cannabinoid users.

Who makes Dronabinol?

Dronabinol is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker YCBD. The company is conducting clinical research on the drug for drug abuse and medication-related indications.

What phase is Dronabinol in?

Dronabinol is in Phase 1 of clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effects.

What clinical trials is Dronabinol in?

Dronabinol has one completed clinical trial, registered under NCT02094599, titled "A Study of the Abuse Potential of Dronabinol in Recreational Cannabinoid Users." The study was a Phase 1, double-blind, uncontrolled trial conducted in Canada with 43 participants.

Is Dronabinol the same as other drugs?

Dronabinol is a distinct drug being developed by cbdMD, Inc. It is a small molecule and is being studied for its effects in drug abuse and medication-related conditions, based on its clinical trial in recreational cannabinoid users.