A 4-week Pilot Study with the Cannabinoid Receptor Agonist Dronabinol and Its Effect on Metabolic Parameters in a Randomized Trial

Zachary Wilmer Reichenbach, Joshua Sloan, Amna Rizvi-Toner, Levent Bayman, Jessica Valestin, Ron Schey

Research output: Contribution to journalArticle

Abstract

Purpose Dronabinol (synthetic Δ9- 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. Findings 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. Implications 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.

Original languageEnglish (US)
Pages (from-to)2267-2274
Number of pages8
JournalClinical Therapeutics
Volume37
Issue number10
DOIs
StatePublished - Oct 1 2015
Externally publishedYes

Fingerprint

Cannabinoid Receptor Agonists
Dronabinol
Placebos
Chest Pain
Hypersensitivity
Appetite
Aspartate Aminotransferases
Leptin
Alanine Transaminase
Double-Blind Method
Mental Disorders
C-Reactive Protein
Nausea
Vomiting
Comorbidity
Heart Diseases
Acquired Immunodeficiency Syndrome
Body Mass Index
Insulin
Glucose

Keywords

  • cannabinoid receptors
  • CB agonist
  • metabolic parameters
  • noncardiac chest pain

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

A 4-week Pilot Study with the Cannabinoid Receptor Agonist Dronabinol and Its Effect on Metabolic Parameters in a Randomized Trial. / Reichenbach, Zachary Wilmer; Sloan, Joshua; Rizvi-Toner, Amna; Bayman, Levent; Valestin, Jessica; Schey, Ron.

In: Clinical Therapeutics, Vol. 37, No. 10, 01.10.2015, p. 2267-2274.

Research output: Contribution to journalArticle

Reichenbach, Zachary Wilmer ; Sloan, Joshua ; Rizvi-Toner, Amna ; Bayman, Levent ; Valestin, Jessica ; Schey, Ron. / A 4-week Pilot Study with the Cannabinoid Receptor Agonist Dronabinol and Its Effect on Metabolic Parameters in a Randomized Trial. In: Clinical Therapeutics. 2015 ; Vol. 37, No. 10. pp. 2267-2274.
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