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
  Purpose

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.


Condition Intervention Phase
Chest Pain
Drug: Marinol
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Frequency of chest pain episodes [ Time Frame: Baseline and 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: February 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Marinol Drug: Marinol
5mg BID, orally for 1 month
Placebo Comparator: Placebo Drug: Placebo
5mg BID, orally for 1 month

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01598207

Contacts
Contact: Yehudith Assouline-Dayan, MD 319-356-7209 yehudith-assouline-dayan@uiowa.edu
Contact: Jessica Valestin 319-384-9756 jessica-valestin@uiowa.edu

Locations
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Yehudith Assouline-Dayan, MD    319-356-7209    yehudith-assouline-dayan@uiowa.edu   
Contact: Jessica Valestin    319-384-9756    jessica-valestin@uiowa.edu   
Principal Investigator: Yehudith Assouline-Dayan, MD         
Sponsors and Collaborators
University of Iowa
  More Information

No publications provided

Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT01598207     History of Changes
Other Study ID Numbers: 201003768
Study First Received: May 10, 2012
Last Updated: July 16, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014