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

NCT ID: NCT01598207

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2014-05-31

Brief 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.

Conditions

Chest Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Marinol

Group Type: EXPERIMENTAL

Marinol

Intervention Type: DRUG

5mg BID, orally for 1 month

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

5mg BID, orally for 1 month

Interventions

Marinol

5mg BID, orally for 1 month

Intervention Type: DRUG

Placebo

5mg BID, orally for 1 month

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yehudith Assouline-Dayan

OTHER

Sponsor Role: lead

Responsible Party

Yehudith Assouline-Dayan

Clinical Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Countries

United States

References

Reichenbach ZW, Sloan J, Rizvi-Toner A, Bayman L, Valestin J, Schey R. A 4-week pilot study with the cannabinoid receptor agonist dronabinol and its effect on metabolic parameters in a randomized trial. Clin Ther. 2015 Oct 1;37(10):2267-74. doi: 10.1016/j.clinthera.2015.07.023. Epub 2015 Aug 14.

Reference Type: DERIVED

PMID: 26283236 (View on PubMed)

Other Identifiers

201003768

Identifier Type: -

Identifier Source: org_study_id