MedPath

Dronabinol

Generic Name
Dronabinol
Brand Names
Marinol, Sativex, Syndros
Drug Type
Small Molecule
Chemical Formula
C21H30O2
CAS Number
1972-08-3
Unique Ingredient Identifier
7J8897W37S
Background

Dronabinol (marketed as Marinol) is a synthetic form of delta-9-tetrahydrocannabinol (Δ⁹-THC), the primary psychoactive component of cannabis (marijuana). THC demonstrates its effects through weak partial agonist activity at Cannabinoid-1 (CB1R) and Cannabinoid-2 (CB2R) receptors, which results in the well-known effects of smoking cannabis such as increased appetite, reduced pain, and changes in emotional and cognitive processes. Due to its evidence as an appetite stimulant and an anti-nauseant, Dronabinol is approved for use in anorexia associated with weight loss in patients with AIDS and for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments .

Tetrahydrocannabinol (THC) and cannabidiol (CBD) are the two most abundant cannabinoids found naturally in the resin of the marijuana plant, both of which are pharmacologically active due to their interaction with cannabinoid receptors that are found throughout the body . While both CBD and THC are used for medicinal purposes, they have different receptor activity, function, and physiological effects. If not provided in their activated form (such as through synthetic forms like Dronabinol or Nabilone), THC and CBD are obtained through conversion from their precursors, tetrahydrocannabinolic acid-A (THCA-A) and cannabidiolic acid (CBDA), through decarboxylation reactions. This can be achieved through heating, smoking, vaporization, or baking of dried unfertilized female cannabis flowers.

From a pharmacological perspective, Cannabis' diverse receptor profile explains its potential application for such a wide variety of medical conditions. Cannabis contains more than 400 different chemical compounds, of which 61 are considered cannabinoids, a class of compounds that act upon endogenous cannabinoid receptors of the body . The endocannabinoid system is widely distributed throughout the central and peripheral nervous system (via the Cannabinoid Receptors CB1 and CB2) and plays a role in many physiological processes such as inflammation, cardiovascular function, learning, pain, memory, stress and emotional regulation, and the sleep/wake cycle among many others . CB1 receptors are found in both the central and peripheral nervous system, and are most abundant in the hippocampus and amygdala, which are the areas of the brain responsible for short-term memory storage and emotional regulation. CB2 receptors are mainly located in the peripheral nervous system and can be found on lymphoid tissue where they are involved in regulation of immune function .

Indication

Dronabinol is indicated for the treatment of anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

Associated Conditions
Anorexia, Chemotherapy-Induced Nausea and Vomiting

Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain

Phase 2
Completed
Conditions
Abdominal Pain
Pancreatitis, Chronic
Chronic Pain
Interventions
First Posted Date
2012-03-12
Last Posted Date
2014-10-28
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
29
Registration Number
NCT01551511
Locations
🇳🇱

Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands

Neurophysiological Study of Sativex in Multiple Sclerosis (MS) Spasticity

Phase 3
Completed
Conditions
Multiple Sclerosis
Interventions
Drug: Placebo
First Posted Date
2012-02-24
Last Posted Date
2014-01-20
Lead Sponsor
Almirall, S.A.
Target Recruit Count
45
Registration Number
NCT01538225
Locations
🇮🇹

Institute of Experimental Neurology, Milan, Italy

Neuroprotection by Cannabinoids in Huntington's Disease

Phase 2
Completed
Conditions
Huntington's Disease
Interventions
First Posted Date
2011-12-30
Last Posted Date
2013-02-01
Lead Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Target Recruit Count
25
Registration Number
NCT01502046
Locations
🇪🇸

Hospital Universitario Ramón y Cajal, Madrid, Spain

Comparative Bioavailability of Dronabinol Oral Solution Versus Branded Capsule 5 mg Under Fasting Conditions

Phase 1
Completed
Conditions
Bioavailability
Interventions
First Posted Date
2011-10-07
Last Posted Date
2012-03-26
Lead Sponsor
INSYS Therapeutics Inc
Target Recruit Count
88
Registration Number
NCT01448772
Locations
🇺🇸

Worldwide Clinical Trials Drug Development Solutions, Austin, Texas, United States

Effects of Dronabinol (Oral THC) on Cannabis Use

Phase 1
Completed
Conditions
Marijuana Smoking
Interventions
First Posted Date
2011-07-14
Last Posted Date
2017-08-03
Lead Sponsor
Johns Hopkins University
Target Recruit Count
25
Registration Number
NCT01394185
Locations
🇺🇸

Johns Hopkins University (Bayview Campus), Baltimore, Maryland, United States

Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions

Phase 1
Completed
Conditions
To Determine Bioequivalence Under Fasting Conditions
Interventions
First Posted Date
2011-06-27
Last Posted Date
2011-06-27
Lead Sponsor
Par Pharmaceutical, Inc.
Target Recruit Count
69
Registration Number
NCT01380457
Locations
🇺🇸

BASi, Baltimore, Maryland, United States

Study to Evaluate the Effect of Rifampicin, Ketoconazole, and Omeprazole on the Pharmacokinetics of Sativex

Phase 1
Completed
Conditions
Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a CYP2C19 Inhibitor
Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Known Inducer of CYP3A4
Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Potent Inhibitor of CYP3A4
Interventions
First Posted Date
2011-03-25
Last Posted Date
2023-04-10
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
36
Registration Number
NCT01323465
Locations
🇬🇧

Guy's Drug Research Unit, Quintiles Ltd., London, United Kingdom

Abuse Potential of Sativex

Phase 1
Completed
Conditions
Evaluation of Abuse Potential of Sativex
Interventions
First Posted Date
2011-03-25
Last Posted Date
2023-04-10
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
58
Registration Number
NCT01323569
Locations
🇨🇦

DecisionLine Clinical Research Corporation, Toronto, Ontario, Canada

Study to Assess Food Effect on Sativex Bioavailability

Phase 1
Completed
Conditions
Food Effect
Interventions
First Posted Date
2011-03-24
Last Posted Date
2023-04-10
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
25
Registration Number
NCT01322464
Locations
🇬🇧

Guy's Drug Research Unit, Quintiles Ltd., London, United Kingdom

Sativex Thorough QT/QTc Study

Phase 1
Completed
Conditions
Effects of Sativex on ECG
Interventions
Drug: Placebo spray and oral moxifloxacin placebo
Drug: Placebo spray and moxifloxacin
First Posted Date
2011-03-24
Last Posted Date
2023-04-10
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
258
Registration Number
NCT01322139
Locations
🇨🇦

DecisionLine Clinical Research Corporation, Toronto, Ontario, Canada

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