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

N-acetylcysteine Effects on Tetrahydrocannabinol

Early Phase 1
Terminated
Conditions
Healthy
Interventions
First Posted Date
2015-01-09
Last Posted Date
2022-01-31
Lead Sponsor
Yale University
Target Recruit Count
5
Registration Number
NCT02335060
Locations
🇺🇸

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

A Study to Evaluate the Pharmacokinetics Of Sativex® in Subjects With Severe Renal Impairment or End Stage Renal Disease, Compared to Matched Subjects With Normal Renal Function.

Phase 1
Withdrawn
Conditions
Renal Insufficiency
Kidney Disease
Interventions
First Posted Date
2014-12-24
Last Posted Date
2016-08-11
Lead Sponsor
GW Pharmaceuticals Ltd
Registration Number
NCT02325024

An Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics (PK) of Sativex® in Healthy Subjects With Cannabis Experience.

First Posted Date
2014-12-24
Last Posted Date
2022-12-20
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
14
Registration Number
NCT02325011
Locations
🇺🇸

Anaheim Clinical Trials, Anaheim, California, United States

Influence of a Medicinal Cannabinoid Agonist on Responses to Food Images and Food Intake

Not Applicable
Active, not recruiting
Conditions
Appetite Regulation
Interventions
Drug: Placebo
First Posted Date
2014-12-08
Last Posted Date
2024-07-10
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
Target Recruit Count
18
Registration Number
NCT02310347
Locations
🇧🇪

University Hospitals Leuven, campus Gasthuisberg, Leuven, Belgium

Effects of THC and CBD on Human Episodic Memory Function

Not Applicable
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2014-11-14
Last Posted Date
2015-01-16
Lead Sponsor
Central Institute of Mental Health, Mannheim
Target Recruit Count
20
Registration Number
NCT02291562
Locations
🇩🇪

Central Institute of Mental Health, Mannheim, Germany

Processing of Salient Emotional Stimuli as a Function of Tetrahydrocannabinol (THC) and Cannabidiol (CBD)

Not Applicable
Completed
Conditions
Healthy Humans
Interventions
First Posted Date
2014-11-14
Last Posted Date
2015-01-16
Lead Sponsor
Central Institute of Mental Health, Mannheim
Target Recruit Count
20
Registration Number
NCT02291536
Locations
🇩🇪

Central Institute of Mental Health, Mannheim, Germany

Anesthetic Premedication With a Cannabis Extract (Cannapremed)

Phase 2
Recruiting
Conditions
Postoperative Nausea and Vomiting
Pain, Postoperative
Anxiety
Interventions
Drug: Dummy oromucosal
First Posted Date
2014-11-05
Last Posted Date
2024-02-28
Lead Sponsor
Hadassah Medical Organization
Target Recruit Count
200
Registration Number
NCT02283281
Locations
🇮🇱

Hasassah - Hebrew University Ein Kerem Medical Center, Jerusalem, Israel

Experimental Medicine in ADHD - Cannabinoids

Not Applicable
Completed
Conditions
Attention Deficit Hyperactivity Disorder (ADHD)
Interventions
First Posted Date
2014-09-25
Last Posted Date
2020-12-04
Lead Sponsor
King's College London
Target Recruit Count
30
Registration Number
NCT02249299
Locations
🇬🇧

Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, King's College London, London, United Kingdom

A Randomised, Open-label, Three-way Crossover Study to Assess the Pharmacokinetics and Safety of Single Doses of Four Sprays of Sativex® in a Range of Oral pH Environments in Healthy Subjects

Phase 1
Terminated
Conditions
Healthy Volunteers
Interventions
First Posted Date
2014-09-15
Last Posted Date
2021-02-05
Lead Sponsor
GW Pharmaceuticals Ltd
Target Recruit Count
6
Registration Number
NCT02240160

The Role of the Endocannabinoid System in Sweet Taste Intensity and Liking

Not Applicable
Completed
Conditions
Sensory Science
Interventions
First Posted Date
2014-04-11
Last Posted Date
2017-05-23
Lead Sponsor
Wageningen University
Target Recruit Count
10
Registration Number
NCT02112292
Locations
🇳🇱

Wageningen University, Wageningen, Gelderland, Netherlands

© Copyright 2025. All Rights Reserved by MedPath