II. Indications
- See Cachexia in Cancer
- See Geriatric Failure to Thrive
- See Nausea in Terminally Ill Patients
- Synthetic Tetrahydrocannabinol (THC)
- Anorexia in Chronic Renal Failure
- Chemotherapy induced Nausea or Vomiting
- Cachexia in AIDS
- Purified Cannabidiol (CBD, Epidiolex)
- Lennox–Gastaut Syndrome (rare Seizure Disorder)
- Dravet Syndrome (rare Seizure Disorder)
- Combined THC and CBD
- Chronic Neuropathic pain
- Oral Mucosal spray and oral agents may offer small pain relief (NNT 10)
- May also demonstrate small improvement in sleep quality and physical functioning
- High THC to CBD ratios offer greatest relief, but also are with the greatest adverse effects
- Busse (2021) BMJ 374: n2040 [PubMed]
- Seehusen (2022) Am Fam Physician 106(2): 202-4 [PubMed]
- Cancer Related Pain
- Reduces mean pain intensity scores, but does not reduce overall pain scores, Insomnia, or Opioid use
- Hauser (2023) Cochrane Database Syst Rev (6): CD014915 [PubMed]
- Chronic Neuropathic pain
III. Mechanism: Two product types derived from Marijuana and Hemp
- Although THC and CBD are the best studied extracts, Cannabis contains more than 60 active substances
- Synthetic Tetrahydrocannabinol (THC)
- THC is the most psychoactive substance in Cannabis
- Will generate a positive Urine Drug Screen
- Purified Cannabidiol (CBD)
- Does not cause the "high" seen with THC (does not cause Intoxication or euphoria)
- However non-regulated CBD products frequently contain intoxicating THC levels
- Typically will not generate a positive Urine Drug Screen (but may if trace THC in product)
IV. Dosing: Cannabidiol (CBD)
- Preparations
- Cannabidiol (Epidiolex) oral solution
- FDA approved in U.S. as of 2018, with a cost of $32,000/year
- DEA Schedule 5
- OTC products (various forms)
- Legal status depends on U.S. State
- Not regulated or studied for efficacy and safety
- Contamination with intoxicating levels of THC are not uncommon
- Contamination with Pesticides and Heavy Metals has also been reported
- Cannabidiol (Epidiolex) oral solution
- Indications: Used to treat rare forms of childhood Epilepsy (age over 2 years)
- Dravet Syndrome
- Lennox-Gastaut Syndrome
- Tuberous Sclerosis
- Dosing
- Dosed 2.5 mg/kg orally twice daily
- Start at 1.25 mg/kg orally twice daily (maintenance 2.5 mg bid) in moderate hepatic dysfunction
- Start at 0.5 mg/kg orally twice daily (maintenance 1 mg bid) in severe hepatic dysfunction
- May increase in weekly increments of 2.5 mg/kg orally twice daily
- Maximum: 20 mg/kg/day divided twice daily (10 mg/kg orally twice daily)
- Decrease maximum dose to 5 mg/kg twice daily in moderate hepatic dysfunction
- Decrease maximum dose to 2 mg/kg twice daily in severe hepatic dysfunction
- Dosed 2.5 mg/kg orally twice daily
- Monitoring: Risk of Hepatocellular Injury (esp. in combination with Valproate, Clobazam)
- Obtain AST, ALT and Total Bilirubin at baseline, 1 month, 3 months and 6 months and then periodically
V. Dosing: Synthetic Tetrahydrocannabinol (THC)
- Nabilone (Cesamet)
- THC analogue used to treat intractable Nausea, Vomiting (e.g. Chemotherapy)
- DEA Schedule 2
- Dosing
- Start 1 mg orally twice daily
- May increase to 2 mg orally twice daily as needed
- Maximum: 6 mg/day in divided doses
- Dronabinol (Marinol, Syndros)
- THC formulation Indicated for intractable Nausea, Vomiting (e.g. Chemotherapy, AIDS-related Anorexia)
- DEA Schedule 3 (misuse is less likely due to formulation)
- Chemotherapy-Induced Nausea or Vomiting (based on BSA in all ages)
- Dose 5 mg/m2 orally 1 to 3 hours before Chemotherapy
- May repeat 5 mg/m2 dose every 2 to 4 hours as needed up to 4 to 6 doses per day
- Maximum: 15 mg/m2
- Anorexia in AIDS
- Start: 2.5 mg orally (or SL, PR) twice daily
- May increase to 5 to 10 mg orally twice daily
- Maximum: 20 mg/day
VI. Drug Interactions: Cannabidiol (CBD)
- Cannabidiol inhibits CYP2C19, CYP2C8, CYP2C9
- Increases levels of Citalopram, Phenytoin, Amitriptyline, Valproic Acid, Warfarin
- Cannabidiol levels may be lowered
- Strong CYP3A4 Inducers lower CBD levels (e.g. St. John's Wort, Carbamazepine, Phenytoin, Rifampin)
- Strong CYP3A4 inhibitors raise CBD levels (e.g. Clarithromycin)
VII. Protocol: Chronic Neuropathic Pain
- Start with Cannabidiol (CBD) spray, tablet or sublingual oil drops
- Initial: 5 mg orally twice daily
- Next: Increase total daily dose by 10 mg up to every 2 to 3 days to a maximum of 40 mg/day
- Add Tetrahydrocannabinol (THC)
- Initial: 1 to 2.5 mg/day
- Next: Increase by 1 to 2.5 mg/day every 2 to 7 days to a maximum of 40 mg/day
- References
- (2022) Am Fam Physician 106(2): 208-9
- Busse (2021) BMJ 374:n2040 +PMID: 34497062 [PubMed]
VIII. Adverse Effects: CBD
- Drowsiness or sedation (esp. in combination with other CNS Depressants, Alcohol, Sedative Hypnotics)
- Diarrhea
- Liver Function Test abnormalities
IX. Safety
- Avoid THC and CBD in pregnancy, Lactation and those taking multiple medications
- Check CBD product for a certificate of analysis that reports CBD levels, THC levels and contaminants
X. Resources
- Simplified Guideline for prescribing Medical Cannabinoids in Primary Care
- Dronabinol (DailyMed)
- Nabilone (DailyMed)
XI. References
- (2019) Presc Lett 26(6)
- (2018) Presc Lett 25(4)
- (2018) Presc Lett 25(9):51
- (2019) Med Lett Drugs Ther 61(1585): 179-82 [PubMed]
Images: Related links to external sites (from Bing)
Related Studies
dronabinol (on 12/21/2022 at Medicaid.Gov Survey of pharmacy drug pricing) | ||
DRONABINOL 10 MG CAPSULE | Generic | $3.22 each |
DRONABINOL 2.5 MG CAPSULE | Generic | $1.20 each |
DRONABINOL 5 MG CAPSULE | Generic | $2.45 each |
Ontology: Tetrahydrocannabinol (C0039663)
Definition (CHV) | an organic chemical extracted from Marihuana |
Definition (CHV) | an organic chemical extracted from Marihuana |
Definition (CHV) | an organic chemical extracted from Marihuana |
Definition (CHV) | an organic chemical extracted from Marihuana |
Definition (CHV) | an organic chemical extracted from Marihuana |
Definition (MSH) | A psychoactive compound extracted from the resin of Cannabis sativa (marihuana, hashish). The isomer delta-9-tetrahydrocannabinol (THC) is considered the most active form, producing characteristic mood and perceptual changes associated with this compound. |
Definition (NCI_NCI-GLOSS) | A synthetic pill form of delta-9-tetrahydrocannabinol (THC), an active ingredient in marijuana that is used to treat nausea and vomiting associated with cancer chemotherapy. |
Definition (NCI) | A synthetic form of delta-9-tetrahydrocannabinol, a psychoactive substance found in Cannabis sativa. Dronabinol acts directly on the appetite and vomiting control centers in the brain to stimulate appetite and prevent emesis. (NCI04) |
Definition (PDQ) | A synthetic form of delta-9-tetrahydrocannabinol, a psychoactive substance found in Cannabis sativa. Dronabinol acts directly on the appetite and vomiting control centers in the brain to stimulate appetite and prevent emesis. Check for "http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=39707&idtype=1" active clinical trials or "http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=39707&idtype=1&closed=1" closed clinical trials using this agent. ("http://nciterms.nci.nih.gov:80/NCIBrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C867" NCI Thesaurus) |
Concepts | Pharmacologic Substance (T121) , Organic Chemical (T109) |
MSH | D013759 |
SnomedCT | 386846008, 72024007, 108415005, 96225007 |
LNC | LP16059-5, MTHU003348 |
English | delta(1)-Tetrahydrocannabinol, delta(1)-THC, delta(9)-Tetrahydrocannabinol, delta(9)-THC, THC, 6H-Dibenzo(b,d)pyran-1-ol, 6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-, (6aR-trans)-, 9 ene Tetrahydrocannabinol, 9-ene-Tetrahydrocannabinol, Delta 9-Tetrahydrocannabinol, Tetrahydrocannabinol, Synthetic delta-9-Tetrahydrocannabinol, delta-9-tetrahydrocannabinol, DELTA THC 09, dronabinol (medication), DRONABINOL, tetrahydrocannabinol (THC), Dronabinol, dronabinol, Dronabinol [Chemical/Ingredient], (-)-.DELTA.9-Tetrahydrocannabinol, tetrahydrocannabinol, delta-9-Tetrahydrocannabinol, Dronabinol (product), Dronabinol (substance), Tetrahydrocannabinol (substance), delta-9-Tetrahydrocannabinol (substance), delta 9-tetrahydrocannabinol |
Swedish | Tetrahydrocannabinol |
Spanish | delta-9-tetrahidrocannabinol (sustancia), delta-9-tetrahidrocanabinol sintético, delta-9-tetrahidrocanabinol, delta-9-tetrahidrocannabinol, delta-9-tetrahidrocanabinol (sustancia), Dronabinol, Tetrahidrocannabinol, Not Translated[Dronabinol], dronabinol (producto), dronabinol (sustancia), dronabinol, tetrahidrocanabinol (sustancia), tetrahidrocanabinol, THC, delta(9)-THC |
Czech | tetrahydrokanabinol |
Finnish | Tetrahydrokannabinoli |
Italian | THC, Delta(1)-THC, Delta(1)-tetraidrocannabinolo, Delta(9)-THC, Delta(9)-tetraidrocannabinolo, 9-ene-tetraidrocannabinolo, Dronabinolo, Tetraidrocannabinolo |
Russian | TETRAGIDROKANNABINOL, DRONABINOL, ТЕТРАГИДРОКАННАБИНОЛ, ДРОНАБИНОЛ, DELTA (9)-THC, THC |
Japanese | テトラヒドロカンナビノール, デルタ9THC, ドロナビノール, Δ1-3,4-trans-テトラヒドロカンナビノール |
German | DELTA THC 09, Delta(9)-THC, Dronabinol, THC, Tetrahydrocannabinol |
Polish | Tetrahydrokannabinol |
French | D9-THC, THC (TétraHydroCannabinol), Dronabinol, Tétrahydrocannabinol |
Portuguese | Not Translated[Dronabinol], Tetra-Hidrocanabinol, Dronabinol, THC, delta (9)-THC |
Ontology: nabilone (C0068333)
Definition (NCI) | A synthetic cannabinoid and dibenzopyrane derivative with anti-emetic activity. Although the mechanism of action has not been fully elucidated yet, it has been suggested that nabilone is a highly selective and strong agonist for the cannabinoid receptors CB1 and CB2, both of which are coupled to Gi/o proteins. The CB1 receptors are expressed predominantly in central and peripheral neurons and receptor stimulation has been implicated in the reduction of chemotherapy-induced nausea. |
Definition (PDQ) | A synthetic cannabinoid and dibenzopyrane derivative with anti-emetic activity. Although the mechanism of action has not been fully elucidated yet, it has been suggested that nabilone is a highly selective and strong agonist for the cannabinoid receptors CB1 and CB2, both of which are coupled to Gi/o proteins. The CB1 receptors are expressed predominantly in central and peripheral neurons and receptor stimulation has been implicated in the reduction of chemotherapy-induced nausea. Check for "http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=39760&idtype=1" active clinical trials or "http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=39760&idtype=1&closed=1" closed clinical trials using this agent. ("http://nciterms.nci.nih.gov:80/NCIBrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C1171" NCI Thesaurus) |
Concepts | Pharmacologic Substance (T121) , Organic Chemical (T109) |
MSH | C011941 |
SnomedCT | 322124005, 395806009 |
English | 3-(1,1-dimethylheptyl)-6,6a,7,8,10,10a- hexahydro-1-hydroxy-6,6-dimethyl-9H-dibenzo(b,d)pyran-9-one, nabilone, NABILONE, nabilone [Chemical/Ingredient], Nabilone, Nabilone (product), Nabilone (substance) |
Spanish | nabilona (producto), nabilona (sustancia), nabilona |
Ontology: Marinol (C0728767)
Concepts | Pharmacologic Substance (T121) , Organic Chemical (T109) |
MSH | D013759 |
Italian | Marinolo, Tetraidrocannabinolo, Solvay |
English | marinol, Marinol, Solvay Brand of Tetrahydrocannabinol |
Ontology: Cesamet (C1263104)
Concepts | Organic Chemical (T109) , Pharmacologic Substance (T121) |
MSH | C011941 |
English | cesamet, Lilly Brand of Nabilone, Cesamet |
Ontology: Synthetic cannabinoid receptor agonist (C1720260)
Concepts | Organic Chemical (T109) , Pharmacologic Substance (T121) |
SnomedCT | 421537003, 422207008 |
English | Synthetic cannabinoid receptor agonist (product), Synthetic cannabinoid receptor agonist (substance), Synthetic cannabinoid receptor agonist |
Spanish | agonista sintético del receptor canabinoide (producto), agonista sintético del receptor canabinoide, agonista sintético del receptor canabinoide (sustancia) |