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

Cannabis and Schizophrenia: Self-Medication and Agonist Treatment

Phase 1
Completed
Conditions
Cannabis Use Disorder
Psychotic Disorder
Schizophrenia
Dual Diagnosis
Schizoaffective Disorder
Interventions
First Posted Date
2009-07-27
Last Posted Date
2021-07-12
Lead Sponsor
Dartmouth-Hitchcock Medical Center
Target Recruit Count
12
Registration Number
NCT00946348
Locations
🇺🇸

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States

Marijuana Drug Discrimination and Self-Administration

Completed
Conditions
Marijuana Abuse
Interventions
First Posted Date
2009-07-22
Last Posted Date
2016-04-28
Lead Sponsor
Wayne State University
Target Recruit Count
29
Registration Number
NCT00943930
Locations
🇺🇸

Wayne State University, Detroit, Michigan, United States

The Effect of Prescription Medications in Marijuana Users

Phase 1
Completed
Conditions
Marijuana Abuse
Interventions
First Posted Date
2009-05-05
Last Posted Date
2017-08-03
Lead Sponsor
Johns Hopkins University
Target Recruit Count
24
Registration Number
NCT00893074
Locations
🇺🇸

Behavioral Pharmacology Research Unit, Baltimore, Maryland, United States

Sativex for Treatment of Chemotherapy Induced Neuropathic Pain

Phase 3
Completed
Conditions
Neuropathic Pain
Interventions
First Posted Date
2009-03-31
Last Posted Date
2014-03-07
Lead Sponsor
Mary Lynch
Target Recruit Count
16
Registration Number
NCT00872144
Locations
🇨🇦

Queen Elizabeth II Health Sciences Centre, Pain Management Unit, Halifax, Nova Scotia, Canada

Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS)

Not Applicable
Completed
Conditions
Cramps
Amyotrophic Lateral Sclerosis
First Posted Date
2008-12-22
Last Posted Date
2009-02-19
Lead Sponsor
Cantonal Hospital of St. Gallen
Target Recruit Count
24
Registration Number
NCT00812851
Locations
🇨🇭

Kantonsspital St.Gallen, St.Gallen, Switzerland

Cannabinoid Receptor (CB1) Agonist Treatment in Severe Chronic Anorexia Nervosa

Phase 3
Completed
Conditions
Anorexia Nervosa
Interventions
Drug: placebo
First Posted Date
2008-09-26
Last Posted Date
2013-05-10
Lead Sponsor
Odense University Hospital
Target Recruit Count
24
Registration Number
NCT00760695
Locations
🇩🇰

Odense University Hospital, Odense, Denmark

Prevention of Postoperative Nausea and Vomiting (PONV) in Surgical Patients

Not Applicable
Completed
Conditions
Postoperative Nausea and Vomiting
Interventions
First Posted Date
2008-09-23
Last Posted Date
2016-05-13
Lead Sponsor
VA Office of Research and Development
Target Recruit Count
216
Registration Number
NCT00757822
Locations
🇺🇸

Central Arkansas Veterans Healthcare System-John L McClellan Memorial Veterans Hospital, Little Rock, Arkansas, United States

Comparison of the Analgesic Effects of Dronabinol and Smoked Marijuana in Daily Marijuana Smokers

First Posted Date
2008-08-28
Last Posted Date
2017-12-11
Lead Sponsor
New York State Psychiatric Institute
Target Recruit Count
34
Registration Number
NCT00743119
Locations
🇺🇸

New York State Psychiatric Institute, New York, New York, United States

A Study to Determine the Maintenance of Effect After Long-term Treatment of Sativex® in Subjects With Neuropathic Pain

Phase 3
Completed
Conditions
Pain
Peripheral Neuropathy
Interventions
Drug: Placebo
First Posted Date
2008-07-11
Last Posted Date
2023-05-03
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
19
Registration Number
NCT00713817
Locations
🇬🇧

Pain Management Research, Clinical Trials Unit, Netherwood House, Solihull Hospital, Solihull, West Midlands, United Kingdom

A Study to Compare the Safety and Tolerability of Sativex® in Patients With Neuropathic Pain.

Phase 3
Completed
Conditions
Peripheral Neuropathy
Pain
Interventions
First Posted Date
2008-07-11
Last Posted Date
2023-05-03
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
380
Registration Number
NCT00713323
Locations
🇬🇧

Pain Management Research, Clinical Trials Unit, Netherwood House, Solihull Hospital, Solihull, West Midlands, United Kingdom

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