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

Pharmacogenetics of Cannabinoid Response

Early Phase 1
Completed
Conditions
COMT Gene Polymorphism
Interventions
First Posted Date
2008-05-15
Last Posted Date
2022-03-09
Lead Sponsor
Yale University
Target Recruit Count
72
Registration Number
NCT00678730
Locations
🇺🇸

VA Connecticut Healthcare System, West Haven, Connecticut, United States

Study to Compare the Safety and Tolerability of Sativex® in Patients With Cancer Related Pain

Phase 3
Completed
Conditions
Pain
Cancer
Interventions
Drug: GW-2000-02
First Posted Date
2008-05-12
Last Posted Date
2023-05-03
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
43
Registration Number
NCT00675948
Locations
🇬🇧

Shropshire and Mid-Wales Hospice, Shrewsbury, United Kingdom

A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy

Phase 3
Completed
Conditions
Palliative Care
Pain
Cancer
Interventions
First Posted Date
2008-05-08
Last Posted Date
2023-05-03
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
177
Registration Number
NCT00674609
Locations
🇬🇧

Shropshire and Mid-Wales Hospice, Shrewsbury, United Kingdom

Dronabinol Versus Standard Ondansetron Antiemetic Therapy in Preventing Delayed-Onset Chemotherapy-Induced Nausea and Vomiting

Phase 3
Completed
Conditions
Chemotherapy Induced Nausea and Vomiting
Interventions
Drug: dronabinol/ondansetron
Drug: placebo
First Posted Date
2008-03-25
Last Posted Date
2008-04-03
Lead Sponsor
Solvay Pharmaceuticals
Target Recruit Count
64
Registration Number
NCT00642512
Locations
🇺🇸

Site 943, Rancho Mirage, California, United States

🇺🇸

Site 922, Marietta, Georgia, United States

🇺🇸

Site 905, Southfield, Michigan, United States

and more 40 locations

Dronabinol Versus Placebo in Treatment and Prevention of Highly Active Anti-Retroviral Therapy (HAART)-Related Nausea and Vomiting

Phase 2
Completed
Conditions
Highly Active Antiretroviral Therapy (HAART)-Related Nausea and Vomiting
HIV Infections
Interventions
Drug: Placebo
First Posted Date
2008-03-25
Last Posted Date
2008-04-02
Lead Sponsor
Solvay Pharmaceuticals
Target Recruit Count
103
Registration Number
NCT00642499
Locations
🇺🇸

Site 914, Chicago, Illinois, United States

🇺🇸

Site 929, Sarasota, Florida, United States

🇺🇸

Site 952, Tallahassee, Florida, United States

and more 33 locations

Investigating the Acute Effects of THC on Functional Brain Systems

Phase 1
Completed
Conditions
Reward
Tetrahydrocannabinol
Endocannabinoids
Memory
Magnetic Resonance Imaging
Interventions
First Posted Date
2008-03-05
Last Posted Date
2009-02-18
Lead Sponsor
UMC Utrecht
Target Recruit Count
12
Registration Number
NCT00628706
Locations
🇳🇱

University Medical Center Utrecht, Utrecht, Netherlands

Cannabinoid Receptor Function & Alcoholism

Phase 1
Completed
Conditions
Alcoholism
Interventions
Drug: Placebo
First Posted Date
2008-02-27
Last Posted Date
2022-03-11
Lead Sponsor
Yale University
Target Recruit Count
29
Registration Number
NCT00624715
Locations
🇺🇸

VA Connecticut Healthcare System, West Haven, Connecticut, United States

Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer

Phase 3
Completed
Conditions
Chemotherapy-induced Nausea and Vomiting
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
First Posted Date
2007-11-04
Last Posted Date
2020-10-09
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
62
Registration Number
NCT00553059
Locations
🇺🇸

University of Texas M.D. Anderson, Houston, Texas, United States

🇺🇸

CCOP - Greenville, Greenville, South Carolina, United States

🇺🇸

Cancer Research for the Ozarks, Springfield, Missouri, United States

and more 1 locations

A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy.

Phase 2
Completed
Conditions
Palliative Care
Pain
Cancer
Interventions
First Posted Date
2007-09-17
Last Posted Date
2013-06-20
Lead Sponsor
GW Pharmaceuticals Ltd
Target Recruit Count
360
Registration Number
NCT00530764
Locations
🇺🇸

A & A Pain Institute of St. Louis, St. Louis, Missouri, United States

🇨🇦

Vancouver Health Research Center, Victoria, British Columbia, Canada

🇺🇸

Office of Donald H. Berdeaux MD, Great Falls, Montana, United States

and more 106 locations

Ph1 Marinol Interaction Study - Part 2 - 1

Phase 1
Completed
Conditions
Marijuana Dependence
Interventions
Drug: Placebo
First Posted Date
2007-06-22
Last Posted Date
2017-01-12
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Target Recruit Count
12
Registration Number
NCT00490269
Locations
🇺🇸

Uniformed Services University of Health Science, Bethesda, Maryland, United States

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