The Effects of Cannabinoid on Patients With Non-GERD Related Non Cardiac Chest Pain
Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
Participant gender:
Summary
Background: Noncardiac chest pain (NCCP) affects 200,000 new cases annually in USA. It is
associated with poor quality of life and high health care expenditure of 8 Billion Dollars a
year.
Gastroesophageal Reflux Disease(GERD), esophageal motility disorders, and psychological
issues may cause NCCP.
The mechanism(s) for pain continue to be explored and include central and peripheral
hypersensitivity, and mechanophysical abnormalities. Treatment of NCCP has focused on
relieving visceral hypersensitivity through pain modulators, such as tricyclics, trazodone,
or adenosine receptor antagonist, theophylline. Typically, only 40-50 % respond and clearly
there is a large unmet therapeutic need.
Cannabis is felt to be beneficial for vomiting, diarrhea and intestinal pain. The main
component of Cannabis acts through specific receptors, that are located primarily on central
and peripheral neurons (including the enteric nervous system) and myenteric plexus where they
modulate neurotransmitter release. Activation of these receptors reduces excitatory enteric
transmission and may improve esophageal hyperreactivity and hypersensitivity, the hallmarks
of NCCP.
STUDY PROTOCOL: The investigators will randomize 40 subjects with non-cardiac, non-reflux
chest pain to receive dronabinol (5 mg Bid), or placebo for 4 weeks. Chest pain symptoms and
esophageal sensorimotor properties will be assessed at baseline and at 4 weeks using symptom
diary and impedance planimetry. The primary outcome measure will be the frequency of chest
pain episodes. Secondary outcome measures include improvement in esophageal sensory
thresholds, reduced reactive contractions, frequency, amplitude, area under the curve, and
global improvement of symptoms.
HYPOTHESIS: Cannabinoids decrease esophageal hypersensitivity and ameliorate chest pain in
NCCP patients, when compared to placebo.
AIM: To perform a randomized double blind study to investigate the effects of Dronabinol, a
CB1 and CB2 agonist, in the treatment of patients with NCCP and examine its mechanism of
action.