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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

Effect of Cannabinoid Agonist on Gastrointestinal and Colonic Motor Functions in Patients With Irritable Bowel Syndrome (IBS)

Phase 2
Completed
Conditions
Irritable Bowel Syndrome
Interventions
Drug: Placebo
First Posted Date
2010-12-03
Last Posted Date
2013-05-07
Lead Sponsor
Mayo Clinic
Target Recruit Count
36
Registration Number
NCT01253408
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

The Effects of Cannabidiol and ∆-9-THC in Humans

Early Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-08-12
Last Posted Date
2022-01-31
Lead Sponsor
Yale University
Target Recruit Count
27
Registration Number
NCT01180374
Locations
🇺🇸

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

Efficacy Trial of Oral Tetrahydrocannabinol in Patients With Fibromyalgia

Not Applicable
Conditions
Fibromyalgia
Interventions
First Posted Date
2010-06-23
Last Posted Date
2010-06-23
Lead Sponsor
Hadassah Medical Organization
Target Recruit Count
80
Registration Number
NCT01149018
Locations
🇮🇱

Pain Relief Unit, Hadassah Medical Organisation, Jerusalem, Israel

Marinol in Trichotillomania or Obsessive Compulsive Disorder

Phase 2
Completed
Conditions
Obsessive Compulsive Disorder
Trichotillomania
Interventions
First Posted Date
2010-03-26
Last Posted Date
2023-02-23
Lead Sponsor
University of Chicago
Target Recruit Count
14
Registration Number
NCT01093976
Locations
🇺🇸

Ambulatory Research Center, Minneapolis, Minnesota, United States

Antagonist-Elicited Cannabis Withdrawal

Phase 1
Completed
Conditions
Cannabis
Dependence
First Posted Date
2009-12-31
Last Posted Date
2017-07-02
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Registration Number
NCT01041170
Locations
🇺🇸

National Institute on Drug Abuse, Biomedical Research Center (BRC), Baltimore, Maryland, United States

🇺🇸

University of Maryland, Baltimore, Baltimore, Maryland, United States

Effects of Sativex(Registered Trademark) and Oral THC on Attention, Affect, Working Memory, Reversal Learning, Physiology and Brain Activation

Phase 1
Completed
Conditions
Cannabis Abuse
Dependence
Pharmacokinetics
fMRI
Cannabis
First Posted Date
2009-12-23
Last Posted Date
2017-07-02
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Target Recruit Count
108
Registration Number
NCT01037608
Locations
🇺🇸

National Institute on Drug Abuse, Biomedical Research Center (BRC), Baltimore, Maryland, United States

Combined Pharmacotherapy for Cannabis Dependency

Phase 2
Completed
Conditions
Cannabis Dependence
Marijuana Dependence
Interventions
First Posted Date
2009-11-25
Last Posted Date
2019-04-24
Lead Sponsor
New York State Psychiatric Institute
Target Recruit Count
156
Registration Number
NCT01020019
Locations
🇺🇸

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

Effects of Delta-9-THC and Iomazenil in Healthy Humans

Early Phase 1
Completed
Conditions
Schizophrenia
Mental Disorders
Psychotic Disorders
Interventions
Drug: Placebo (control)
First Posted Date
2009-09-23
Last Posted Date
2022-12-05
Lead Sponsor
Yale University
Target Recruit Count
17
Registration Number
NCT00982982
Locations
🇺🇸

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

Add on Study on Δ9-THC Treatment for Posttraumatic Stress Disorders (PTSD)

Phase 4
Conditions
Posttraumatic Stress Disorders
Interventions
First Posted Date
2009-08-26
Last Posted Date
2012-10-30
Lead Sponsor
Hadassah Medical Organization
Target Recruit Count
70
Registration Number
NCT00965809
Locations
🇮🇱

Hadassah Medical Organization, Jerusalem, Israel

Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Central Neuropathic Pain Related to Multiple Sclerosis

Phase 3
Completed
Conditions
Central Neuropathic Pain in Multiple Sclerosis
Interventions
Drug: Placebo
First Posted Date
2009-08-14
Last Posted Date
2012-02-03
Lead Sponsor
Bionorica Research GmbH
Target Recruit Count
240
Registration Number
NCT00959218
Locations
🇩🇪

Maerkische Kliniken GmbH, Klinikum Luedenscheid, Akademisches Lehrkrankenhaus der Universitaet Bonn, Klinik fuer Neurologie, Luedenscheid, Germany

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