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

Probing the Cannabinoid System in Individuals With a Family History of Psychosis

Early Phase 1
Active, not recruiting
Conditions
Schizophrenia
Marijuana
Psychosis
Cannabis Use
THC
Interventions
Drug: Placebo
Drug: Very Low Dose THC
First Posted Date
2014-04-02
Last Posted Date
2024-08-13
Lead Sponsor
Yale University
Target Recruit Count
21
Registration Number
NCT02102113
Locations
🇺🇸

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

A Study of the Abuse Potential of Dronabinol in Recreational Cannabinoid Users

Phase 1
Completed
Conditions
Drug Abuse, Medication
Interventions
First Posted Date
2014-03-24
Last Posted Date
2014-05-13
Lead Sponsor
INSYS Therapeutics Inc
Target Recruit Count
43
Registration Number
NCT02094599
Locations
🇨🇦

INC Research Toronto, Inc., Toronto, Ontario, Canada

An Observational Post-Marketing Safety Registry of Sativex®

Completed
Conditions
Neuropathic Pain
Diabetes
Cancer
Multiple Sclerosis
Interventions
First Posted Date
2014-02-27
Last Posted Date
2022-12-20
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
978
Registration Number
NCT02073474

Cannabinoid Control of Fear Extinction Neural Circuits in Post-traumatic Stress Disorder

Not Applicable
Completed
Conditions
Post-Traumatic Stress Disorder
Interventions
Drug: Placebo
First Posted Date
2014-02-24
Last Posted Date
2022-09-09
Lead Sponsor
Wayne State University
Target Recruit Count
86
Registration Number
NCT02069366
Locations
🇺🇸

Eugene Applebaum College of Pharmacy and Health Sciences, Detroit, Michigan, United States

A Pharmacokinetic Study of Single Doses of Sativex in Treatment-induced Mucositis

Phase 1
Terminated
Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
First Posted Date
2013-11-05
Last Posted Date
2016-08-11
Lead Sponsor
GW Pharmaceuticals Ltd
Target Recruit Count
10
Registration Number
NCT01975688
Locations
🇬🇧

Quintiles London Drug Research Unit, London, United Kingdom

A Randomized Study of Sativex on Cognitive Function and Mood: Multiple Sclerosis Patients

Phase 4
Completed
Conditions
Spasticity
Multiple Sclerosis
Interventions
Drug: Placebo
First Posted Date
2013-10-17
Last Posted Date
2023-01-12
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
121
Registration Number
NCT01964547
Locations
🇨🇿

MS Centre, Charles University, Prague, Czechia

Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment?

Phase 1
Completed
Conditions
Psychotic Disorder
Schizophrenia
Dual Diagnosis
Cannabis Use Disorder
Interventions
First Posted Date
2013-10-17
Last Posted Date
2021-10-13
Lead Sponsor
Dartmouth-Hitchcock Medical Center
Target Recruit Count
261
Registration Number
NCT01964404
Locations
🇺🇸

University of Vermont, Burlington, Vermont, United States

🇺🇸

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

A Safety, Efficacy and Tolerability Study of Sativex for the Treatment of Spasticity in Children Aged 8 to 18 Years

Phase 3
Completed
Conditions
Cerebral Palsy
Interventions
Drug: Placebo
First Posted Date
2013-07-12
Last Posted Date
2022-12-20
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
72
Registration Number
NCT01898520
Locations
🇬🇧

Center 1, London, United Kingdom

🇬🇧

Center 6, Cambridge, United Kingdom

🇨🇿

Center 14, Prague, Czechia

and more 11 locations

Bioequivalence Assessment of Oral Administration Vs. Oral Spray of a Cannabinoids (Tetrahydrocannabinol and Cannabidiol)

Phase 1
Completed
Conditions
Pain
Interventions
Drug: CBD-THC-Piperine-PNL capsule
First Posted Date
2013-07-09
Last Posted Date
2016-03-24
Lead Sponsor
Hadassah Medical Organization
Target Recruit Count
12
Registration Number
NCT01893424
Locations
🇮🇱

Hadassah medical organization, Jerusalem, Israel

Assessment of the Single Dose Pharmacokinetics and Tolerability of Sativex in Patients With Impaired Hepatic Function and Healthy Patients

Phase 1
Completed
Conditions
Hepatic Impairment
Interventions
First Posted Date
2013-06-26
Last Posted Date
2022-12-20
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
32
Registration Number
NCT01887301
Locations
🇺🇸

Anaheim Clinical Trials, LLC, Anaheim, California, United States

🇺🇸

Clinical Pharmacology of Miami, Inc., Miami, Florida, United States

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