Investigation of Cannabinoid Receptor Agonist Dronabinol in Patients With Functional Chest Pain

Withdrawn before enrolling · Phase 4 · Has a placebo group

Conditions studied: Esophageal Diseases

In brief

In a recent study, Dronabinol was shown to reduce symptoms in patients with Functional Chest Pain (non-cardiac chest pain). Additionally, metabolic measures and patients' weights were not adversely affected by this regiment. In fact, some cholesterol measures trended in a favorable direction with Dronabinol. The study lasted 28 days and patients took Dronabinol twice daily. The goal of this current study focuses on reducing the dose of Dronabinol to see if the same goals can be achieved. More so, the study will be extended to 12 weeks to gain a more longitudinal picture of therapy with Dronabinol. It is hypothesized that reducing the dose and extending the duration will continue to show an improvement in symptoms as well as no adverse metabolic outcomes.

Key facts

Study ID

NCT02569073

Run by

Temple University

People needed

0

Starts

2017-06-21

Expected to finish

2019-09-01

Last updated by the study team

2019-09-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least one episode of chest pain a week in the past month. Previous negative cardiac evaluation (EKG ± non invasive stress test ± coronary angiogram). Negative esophageal evaluation for a motility disorder (eg: achalasia) and GERD (normal endoscopy, normal 24 hr pH study, or unresponsive to 6 weeks of BID PPI therapy)

You may not qualify if…

• Subjects requiring narcotics or other pain medications,
• Subjects with known GERD (unless responsive to PPI therapy and on a stable dose), esophagitis, Barrett's esophagus or peptic stricture on endoscopy
• Subjects with previous upper gastrointestinal surgery
• Pregnancy
• Subjects with diabetes, neuromuscular disorders, cardiac disorders, or other severe co-morbidities (Cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic).
• Subjects with upper airway symptoms (such as hoarseness, wheezing or laryngospasm)
• Medications such as baclofen, sucralfate and prokinetic agents or any agent considered a sedative, hypnotic, or psychoactive drug.
• Known history of substance abuse.
• Subject unable to consent.
• Patient has history of comorbid psychiatric conditions including mania and schizophrenia. Patients will also be excluded who currently have a diagnosis of depression or undergoing treatment for depression.

Where it is running

• Temple University Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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