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

NCT02569073 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 22894
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Diseases

Keywords

Functional Chest Pain; Non-Cardiac Chest Pain; Esophageal Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Chest Pain

  Patient will fill out a Chest Pain Questionnaire and symptom diary daily of symptoms which will be normalized to a numerical value for comparison among groups.

  Daily assessment for 12 weeks

Secondary Outcomes (19)

• Chest Pain Intensity

  Daily assessment for 12 weeks

• GERD Symptom Checklist

  Baseline, 2, 4, 8, and 12 weeks

• Short Form 36

  Baseline, 2, 4, 8, and 12 weeks

• Esophageal Hypersensitivity and Distention

  Baseline, 4, 8, and 12 weeks

• Beck Depression Index

  Baseline, 2, 4, 8, and 12 weeks

Study Arms (2)

Dronabinol

EXPERIMENTAL

Patients who receive Dronabinol 5 mg, every other night, orally.

Drug: Dronabinol

Placebo

PLACEBO COMPARATOR

Patients who receive Placebo every other night, orally

Drug: Placebo

Interventions

Dronabinol DRUG

Dronabinol 5 mg, every other night, orally

Also known as: Marinol

Dronabinol

Placebo DRUG

Placebo--no drug

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Esophageal Diseases

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Ron W Schey, M.D.

  Temple University

  PRINCIPAL INVESTIGATOR

• Zachary W Reichenbach, M.D., Ph.D.

  Temple University

  PRINCIPAL INVESTIGATOR

• Henry Parkman, M.D.

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 6, 2015
• Study Start: June 21, 2017
• Primary Completion: August 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)