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
Associated Therapies
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A Safety Study of Sativex Compared With Placebo (Both With Dose-intense Temozolomide) in Recurrent Glioblastoma Patients

Phase 1
Completed
Conditions
Interventions
First Posted Date
2013-03-18
Last Posted Date
2022-12-20
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
21
Registration Number
NCT01812616
Locations
🇩🇪

Klinik für Onkologie, Hämatologie und Stammzelltransplantation, Universitätsklinikum Aachen RWTH, Aachen, Germany

🇩🇪

Neurologie des Klinikums Altenburger Land, Altenburg, Germany

🇩🇪

Zentrum für Neuroonkologie der Universität Duesseldorf, Duesseldorf, Germany

and more 8 locations

Effect of a Cannabinoid Agonist on Colonic Sensory Functions in Patients With Irritable Bowel Syndrome

Phase 2
Completed
Conditions
Interventions
First Posted Date
2013-02-07
Last Posted Date
2013-03-14
Lead Sponsor
Michael Camilleri
Target Recruit Count
75
Registration Number
NCT01786109
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

Safety and Efficacy Study of Dronabinol to Treat Obstructive Sleep Apnea

First Posted Date
2012-12-21
Last Posted Date
2021-07-29
Lead Sponsor
University of Illinois at Chicago
Target Recruit Count
75
Registration Number
NCT01755091
Locations
🇺🇸

University of Illinois at Chicago, Chicago, Illinois, United States

🇺🇸

Northwestern University, Chicago, Illinois, United States

Fixed or Self-Titrated Dosages of Sativex on Cannabis Users

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2012-12-13
Last Posted Date
2016-02-01
Lead Sponsor
Centre for Addiction and Mental Health
Target Recruit Count
16
Registration Number
NCT01748799
Locations
🇨🇦

Centre for Addiction and Mental Health, Toronto, Ontario, Canada

Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence

First Posted Date
2012-12-12
Last Posted Date
2017-10-02
Lead Sponsor
Centre for Addiction and Mental Health
Target Recruit Count
45
Registration Number
NCT01747850
Locations
🇨🇦

Centre for Addiction and Mental Health, Toronto, Ontario, Canada

Safety and Tolerability of Namisol in the Elderly

Phase 1
Completed
Conditions
Interventions
First Posted Date
2012-12-04
Last Posted Date
2014-01-07
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
12
Registration Number
NCT01740960
Locations
🇳🇱

Radboud University Medical Centre, department of Geriatrics, Nijmegen, Gelderland, Netherlands

A Study of Sativex in the Treatment of Central Neuropathic Pain Due to Multiple Sclerosis

First Posted Date
2012-05-23
Last Posted Date
2023-01-10
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
66
Registration Number
NCT01604265
Locations
🇬🇧

Walton Centre for Neurology and Neurosurgery, Liverpool, United Kingdom

The Effects of Cannabinoid on Patients With Non-GERD Related Non Cardiac Chest Pain

Phase 4
Completed
Conditions
Interventions
First Posted Date
2012-05-15
Last Posted Date
2017-04-28
Lead Sponsor
Yehudith Assouline-Dayan
Target Recruit Count
13
Registration Number
NCT01598207
Locations
🇺🇸

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia

First Posted Date
2012-05-15
Last Posted Date
2018-08-29
Lead Sponsor
Mclean Hospital
Target Recruit Count
12
Registration Number
NCT01598896
Locations
🇺🇸

McLean Hospital, Belmont, Massachusetts, United States

A Study to Evaluate the Efficacy of Sativex in Relieving Symptoms of Spasticity Due to Multiple Sclerosis

Phase 3
Completed
Conditions
Interventions
First Posted Date
2012-05-15
Last Posted Date
2023-05-03
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
337
Registration Number
NCT01599234
Locations
🇬🇧

The Royal Berkshire and Battle Hospitals NHS Trust, Reading, United Kingdom

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