The Effects of Cannabinoid on Patients With Non-GERD Related Non Cardiac Chest Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Iowa
Sponsor:
Information provided by (Responsible Party):
University of Iowa
ClinicalTrials.gov Identifier:
NCT01598207
First received: May 10, 2012
Last updated: July 16, 2014
Last verified: July 2014

May 10, 2012
July 16, 2014
February 2011
December 2014   (final data collection date for primary outcome measure)
Frequency of chest pain episodes [ Time Frame: Baseline and 1 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01598207 on ClinicalTrials.gov Archive Site
  • Frequency of chest pain in treatment group vs baseline [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Intensity of chest pain episodes [ Time Frame: Baseline and 1 month ] [ Designated as safety issue: No ]
  • Sensory thresholds for first sensation [ Time Frame: Baseline and 1 month ] [ Designated as safety issue: No ]
  • Frequency of reactive esophageal contractions [ Time Frame: Baseline and 1 month ] [ Designated as safety issue: No ]
  • Amplitude of reactive esophageal contractions [ Time Frame: Baseline and 1 month ] [ Designated as safety issue: No ]
  • Area under the curve of reactive esophageal contractions [ Time Frame: Baseline, 1 month ] [ Designated as safety issue: No ]
  • Duration of chest pain episodes [ Time Frame: Baseline vs 1 month ] [ Designated as safety issue: No ]
  • Sensory thresholds for discomfort [ Time Frame: Baseline and 1 month ] [ Designated as safety issue: No ]
  • Sensory thresholds for pain [ Time Frame: Baseline and 1 month ] [ Designated as safety issue: No ]
Same as current
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The Effects of Cannabinoid on Patients With Non-GERD Related Non Cardiac Chest Pain
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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.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chest Pain
  • Drug: Marinol
    5mg BID, orally for 1 month
  • Drug: Placebo
    5mg BID, orally for 1 month
  • Experimental: Marinol
    Intervention: Drug: Marinol
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
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December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Yehudith Assouline-Dayan, MD 319-356-7209 yehudith-assouline-dayan@uiowa.edu
Contact: Jessica Valestin 319-384-9756 jessica-valestin@uiowa.edu
United States
 
NCT01598207
201003768
Not Provided
University of Iowa
University of Iowa
Not Provided
Not Provided
University of Iowa
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP