The Effects of Cannabinoid on Patients With Non-GERD Related Non Cardiac Chest Pain
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
- Frequency of Chest Pain Episodes [ Time Frame: Baseline and 1 month ]Number of people still experiencing the same amount of chest pain during treatment than previously without
- Frequency of Chest Pain in Treatment Group vs Baseline [ Time Frame: 1 month ]Total (intensity (0(none) - 3(severe) + duration (0(none) - 3(longer than 30 mins)) at end of 1 month treatment; higher represents worse outcome; the total score ranges from 0 to 6 and is the sum of the intensity and duration
- Intensity of Chest Pain Episodes [ Time Frame: Baseline and 1 month ]Intensity (0(none) - 3(severe)) at baseline vs 1 month for chest pain episodes; higher represents worse outcome; multiple chest pain totals are averaged
- Sensory Thresholds for First Sensation [ Time Frame: Baseline and 1 month ]This is determined by the Esophageal Balloon Distension Test; range 0-65 mmHg
- Duration of Chest Pain Episodes [ Time Frame: Baseline vs 1 month ]0 - is none and 3 is longer than 30 mins; higher values is worst outcome; chest pain totals are averaged
- Sensory Thresholds for Discomfort [ Time Frame: Baseline and 1 month ]When participants felt pain at earliest pressure; range 0-65 mmHg
- Sensory Thresholds for Pain [ Time Frame: Baseline and 1 month ]When highest amount of pain was felt; range is 0-65 mmHg
|Study Start Date:||February 2011|
|Study Completion Date:||May 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
5mg BID, orally for 1 month
|Placebo Comparator: Placebo||
5mg BID, orally for 1 month
Please refer to this study by its ClinicalTrials.gov identifier: NCT01598207
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|