A 4-week pilot study with the cannabinoid receptor agonist dronabinol and its effect on metabolic parameters in a randomized trial.
OBJECTIVE
Dronabinol (synthetic Δ(9)- tetrahydrocannabinol) is used in patients with nausea and vomiting from chemotherapy and in AIDS patients for appetite stimulation. Recently, dronabinol was used to successfully treat visceral hypersensitivity causing noncardiac chest pain. With widening uses of this medication, we aim to explore its effects on metabolic parameters in long-term dosing and hypothesize that it will not affect major metabolic parameters.


METHODS
A double-blind, placebo-controlled, 28-day trial was performed with patients 18 to 75 years old without cardiac disease. Patients had at least 2 weekly episodes of chest pain for the last 3 months and evidence of esophageal hypersensitivity after balloon distention testing. Prior use of pain medication, psychiatric diagnosis, or significant medical comorbidities precluded inclusion in the study. Patients were randomized to receive 5 mg dronabinol or placebo twice daily with metabolic parameters examined before and after the use of medication.


RESULTS
Thirteen patients completed the study (7 with dronabinol [6 women and 1 man] and 6 with placebo [5 women and 1 man]). None of the measured values, including body mass index, HDL, triglycerides, calculated LDL, high-sensitivity C-reactive protein, glucose, insulin, leptin, aspartate aminotransferase, alanine aminotransferase, LDH, or non-HDL, differed significantly in either group before or after treatment. In general, treatment with dronabinol coincided with favorable trends in some parameters, although these trends were not statistically significant.


CONCLUSIONS
Dronabinol administration does not significantly affect basic metabolic components after a period of 28 days. The implications of these findings are important because dronabinol may be able to be used in patients with metabolic disorders. The favorable trends observed here warrant further exploration into its long-term effects. ClinicalTrials.gov identifier: NCT01598207.
Division of Gastroenterology, Temple University Hospital, Philadelphia, Pennsylvania; Center for Substance Abuse Research, School of Medicine, Temple University, Philadelphia, Pennsylvania.
Zachary Wilmer
ZW
Reichenbach
Division of Gastroenterology, Temple University Hospital, Philadelphia, Pennsylvania.
Joshua
J
Sloan
Division of Gastroenterology, University of Iowa Hospitals and Clinics, Iowa City, Iowa.
Amna
A
Rizvi-Toner
Division of Gastroenterology, University of Iowa Hospitals and Clinics, Iowa City, Iowa.
Levent
L
Bayman
Division of Gastroenterology, University of Iowa Hospitals and Clinics, Iowa City, Iowa.
Jessica
J
Valestin
Division of Gastroenterology, Temple University Hospital, Philadelphia, Pennsylvania; Division of Gastroenterology, University of Iowa Hospitals and Clinics, Iowa City, Iowa. Electronic address: Ron.Schey@tuhs.temple.edu.
Ron
R
Schey
D000328:Adult; D000368:Aged; D015992:Body Mass Index; D002097:C-Reactive Protein; D063386:Cannabinoid Receptor Agonists / Q000627:therapeutic use*; D002637:Chest Pain / Q000188:drug therapy* / Q000378:metabolism; D004311:Double-Blind Method; D013759:Dronabinol / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000188:drug therapy; D010865:Pilot Projects; D013997:Time Factors; D014839:Vomiting / Q000139:chemically induced / Q000188:drug therapy
D063386:Cannabinoid Receptor Agonists; D013759:Dronabinol; D002097:C-Reactive Protein
CB(1) agonist; cannabinoid receptors; metabolic parameters; noncardiac chest pain