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NCT Number: NCT01598207

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.

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Key information

Conditions

Chest Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Marinol

Drug

5mg BID, orally for 1 month

Placebo

Drug

5mg BID, orally for 1 month

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. Sensory Thresholds for First Sensation

    Time frame: Baseline and 1 month

    This is determined by the Esophageal Balloon Distension Test; range 0-65 mmHg

  4. 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

  5. Sensory Thresholds for Discomfort

    Time frame: Baseline and 1 month

    When participants felt pain at earliest pressure; range 0-65 mmHg

  6. Sensory Thresholds for Pain

    Time frame: Baseline and 1 month

    When highest amount of pain was felt; range is 0-65 mmHg

Sponsors and collaborators

Lead sponsor

Yehudith Assouline-Dayan

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 15, 2012
Registry last updated
Apr 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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