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

Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs

Phase 1
Completed
Conditions
Obstructive Sleep Apnea
Interventions
First Posted Date
2023-05-12
Last Posted Date
2025-01-17
Lead Sponsor
Incannex Healthcare Ltd
Target Recruit Count
125
Registration Number
NCT05857384
Locations
🇦🇺

CMAX, Adelaide, South Australia, Australia

🇦🇺

Nucleus Network Pty Ltd, Melbourne, Victoria, Australia

🇦🇺

Nucleus Network Pty Ltd [Commercial Road], Melbourne, Victoria, Australia

Dronabinol On the Pain Experience

Phase 4
Terminated
Conditions
Trauma Injury
Interventions
Drug: Standard of care
First Posted Date
2023-04-20
Last Posted Date
2025-01-13
Lead Sponsor
The University of Texas Health Science Center, Houston
Target Recruit Count
482
Registration Number
NCT05820685
Locations
🇺🇸

The University of Texas Health Science Center at Houston, Houston, Texas, United States

The Impact of THC on Pain Modulation in Fibromyalgia

Not Applicable
Recruiting
Conditions
Fibromyalgia, Primary
Interventions
Drug: Placebo
First Posted Date
2022-12-09
Last Posted Date
2024-03-26
Lead Sponsor
Tel Aviv Medical Center
Target Recruit Count
40
Registration Number
NCT05644054
Locations
🇮🇱

Tel Aviv Medical Center, Tel Aviv, Israel

Multimodal Magnetoencephalography and Electroencephalography Exploration of the Acute Effects of THC Exposure on Neural Noise and Information Transmission Within Working Memory Networks

Phase 2
Not yet recruiting
Conditions
THC
Interventions
Other: Placebo
First Posted Date
2022-12-08
Last Posted Date
2024-08-21
Lead Sponsor
Yale University
Target Recruit Count
50
Registration Number
NCT05641766
Locations
🇺🇸

VA Connecticut Healthcare System, Yale School of Medicine, West Haven, Connecticut, United States

Dronabinol for Agitation in Dementia Crossover Trial

Phase 2
Withdrawn
Conditions
Dementia Severe
Behavioral Symptoms
Agitation,Psychomotor
Dementia Moderate
Interventions
First Posted Date
2022-11-10
Last Posted Date
2024-07-05
Lead Sponsor
Ralph H. Johnson VA Medical Center
Registration Number
NCT05612711
Locations
🇺🇸

Ralph H. Johnson VA Health Care System, Charleston, South Carolina, United States

Comparison of VER-01 to Opioids in Patients With Chronic Non-specific Low Back Pain

Phase 3
Completed
Conditions
Chronic Non-specific Low Back Pain
Interventions
Drug: Opioid therapy
First Posted Date
2022-11-09
Last Posted Date
2024-11-25
Lead Sponsor
Vertanical GmbH
Target Recruit Count
384
Registration Number
NCT05610813
Locations
🇩🇪

Medizinische Hochschule Hannover (MHH), Hannover, Germany

🇩🇪

Rheumazentrum Prof. Dr. med. Gunther Neeck, Bad Doberan, Germany

Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain

Phase 2
Recruiting
Conditions
Sickle Cell Disease
Interventions
Drug: Placebo
First Posted Date
2022-08-29
Last Posted Date
2024-07-03
Lead Sponsor
Icahn School of Medicine at Mount Sinai
Target Recruit Count
60
Registration Number
NCT05519111
Locations
🇺🇸

Mount Sinai Hospital, New York, New York, United States

Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV

Phase 2
Recruiting
Conditions
Cannabis
THC
HIV
Neuroinflammatory Disease
Neuroinflammatory Response
Microbiome
Interventions
First Posted Date
2022-08-25
Last Posted Date
2025-02-17
Lead Sponsor
University of California, San Diego
Target Recruit Count
90
Registration Number
NCT05514899
Locations
🇺🇸

HIV Neurobehavioral Research Program (HNRP), San Diego, California, United States

Sativex® and Gentamicin for Optimized Pharmagological Treatment in Older Patients (CanPan)

Phase 1
Recruiting
Conditions
Emergency Service, Hospital
Pharmacokinetics
Malnutrition
Cannabis
Renal Function
Anorexia
Aging
Interventions
First Posted Date
2022-08-16
Last Posted Date
2022-09-21
Lead Sponsor
Ove Andersen
Target Recruit Count
17
Registration Number
NCT05503147
Locations
🇩🇰

Clinical Research Centre, Hvidovre, Denmark

The Pharmacodynamics of Cannabinoid-Caffeine Combinations

Early Phase 1
Completed
Conditions
Behavioral Pharmacology of Cannabinoids
Interventions
First Posted Date
2022-07-28
Last Posted Date
2024-10-07
Lead Sponsor
Johns Hopkins University
Target Recruit Count
20
Registration Number
NCT05478863
Locations
🇺🇸

Johns Hopkins University School of Medicine BPRU, Baltimore, Maryland, United States

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