The Effects of Cannabinoid on Patients With Non-GERD Related Non Cardiac Chest Pain
Information source: University of Iowa
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chest Pain
Intervention: Marinol (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Iowa
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Frequency of chest pain episodes
Secondary outcome: Frequency of chest pain in treatment group vs baselineIntensity of chest pain episodes Sensory thresholds for first sensation Frequency of reactive esophageal contractions Amplitude of reactive esophageal contractions Area under the curve of reactive esophageal contractions Duration of chest pain episodes Sensory thresholds for discomfort Sensory thresholds for pain
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or Female
- Ages 18-75 years
- Non-GERD related Non cardiac chest pain (Evaluated previously with an EGD, Esophageal
manometry, and 24 Hour ambulatory pH study)
- At least one episode of chest pain a week in the past month
- Previous negative cardiac evaluation (EKG ± Non invasive stress test ± Coronary
angiogram)
Exclusion Criteria:
- Subjects requiring narcotics or other pain medications
- Subjects with known esophagitis, Barrett's esophagus or peptic stricture on endoscopy
- Subjects with previous upper gastrointestinal surgery
- Pregnancy
- Subjects with Diabetes, neuromuscular disorders, or other severe co-morbidities
(Cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic, and
psychiatric)
- Subjects with upper airway symptoms (such as hoarseness, wheezing or laryngospasm)
- Medications such as baclofen, H2 blockers, PPI, sucralfate and prokinetics.
- Known history of substance abuse
- Nursing mothers
Locations and Contacts
University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States
Additional Information
Starting date: February 2011
Last updated: December 4, 2014
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