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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yehudith Assouline-Dayan, University of Iowa
ClinicalTrials.gov Identifier:
NCT01598207
First received: May 10, 2012
Last updated: April 26, 2017
Last verified: April 2017
  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
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Yehudith Assouline-Dayan, University of Iowa:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 13
Study Start Date: February 2011
Study Completion Date: May 2014
Primary Completion Date: May 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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Yehudith Assouline-Dayan
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yehudith Assouline-Dayan, Clinical Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01598207     History of Changes
Other Study ID Numbers: 201003768
Study First Received: May 10, 2012
Results First Received: March 21, 2016
Last Updated: April 26, 2017

Additional relevant MeSH terms:
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 27, 2017