Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02569073
Recruitment Status : Suspended (Funding)
First Posted : October 6, 2015
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Temple University

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.

Condition or disease Intervention/treatment Phase
Esophageal Diseases Drug: Dronabinol Drug: Placebo Phase 4

Detailed Description:

About 200,000 new cases of Functional Chest Pain (FCP) are diagnosed annually in USA. FCP is associated with poor quality of life and high health care expenditure. Gastroesophageal reflux disease (GERD), esophageal motility disorders, and psychological disorders may cause FCP. However, the mechanism(s) for FCP continue to be explored and include central and peripheral hypersensitivity as well as biomechanical dysfunction of the esophageal wall. CB1 receptor activation in synaptic clefts fine tunes neuronal firing and may in fact quell the over excitation associated with hypersensitivity.

Dronabinol, a cannabinoid receptor agonist with a preference for CB1 over CB2, is believed to reduce the esophageal hypersensitivity. CB1 receptors are located primarily on central and peripheral neurons (including the enteric nervous system) and myenteric plexus where they modulate neurotransmitter release. Activation of pre-junctional CB1 receptors may reduce excitatory enteric transmission and conceivably improve esophageal hyperreactivity and hypersensitivity, the hallmarks of FCP.

Previously, it was shown that Chest Pain Symptoms were greatly reduced when patients took 5 mg Dronabinol twice daily. Patients had very few side effects from this regiment although sedation was reported. The goal of this study focuses on reducing the dose of Dronabinol to 5 mg every other day, or essentially, one quarter of the dose. The effect of Dronabinol varies with CB1 receptor density in various tissues. It is hypothesized that at this reduced dose relief of chest pain will still be achieved without the sedating effects.

More so, Dronabinol at 5 mg twice daily failed to produce any adverse metabolic outcomes including measures of glucose, LDL, triglycerides, leptin, or transaminases. Dronabinol treatment tended to improve some of these measures although the study only lasted 28 days. Currently the hypothesis is that lower doses at a protracted time course will again fail to perturb homeostasis.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Investigation of Cannabinoid Receptor Agonist Dronabinol in Patients With Functional Chest Pain
Actual Study Start Date : June 21, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

Arm Intervention/treatment
Experimental: Dronabinol
Patients who receive Dronabinol 5 mg, every other night, orally.
Drug: Dronabinol
Dronabinol 5 mg, every other night, orally
Other Name: Marinol

Placebo Comparator: Placebo
Patients who receive Placebo every other night, orally
Drug: Placebo
Placebo--no drug




Primary Outcome Measures :
  1. Chest Pain [ Time Frame: Daily assessment for 12 weeks ]
    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.


Secondary Outcome Measures :
  1. Chest Pain Intensity [ Time Frame: Daily assessment for 12 weeks ]
    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.

  2. GERD Symptom Checklist [ Time Frame: Baseline, 2, 4, 8, and 12 weeks ]
    Patients will fill out a questionnaire pertaining to GERD symptoms which will be normalized to a numerical value for comparison among groups.

  3. Short Form 36 [ Time Frame: Baseline, 2, 4, 8, and 12 weeks ]
    A general health-related quality of life questionnaire that examines 8 domains: Physical Functioning, Role Functioning Physical, Role Functioning Emotional, Mental Health, Vitality, Bodily Pain, General Health, and Social Functioning

  4. Esophageal Hypersensitivity and Distention [ Time Frame: Baseline, 4, 8, and 12 weeks ]
    Sensory thresholds for first sensation, discomfort, and pain in the esophagus. Frequency, amplitude, area under the curve (AUC) of reactive esophageal contractions

  5. Beck Depression Index [ Time Frame: Baseline, 2, 4, 8, and 12 weeks ]
    Analysis of depressive symptoms normalized to a numerical value for comparison among groups.

  6. Metabolic Parameters [ Time Frame: Baseline, 2, 4, 8, and 12 weeks ]
    Total cholesterol will be measured and reported in mg/dL.

  7. Weight [ Time Frame: Baseline, 2, 4, 8, and 12 weeks ]
    Patient mass will be measured in kg.

  8. Beck Anxiety Index [ Time Frame: Baseline, 2, 4, 8, and 12 weeks ]
    Analysis of anxious symptoms normalized to a numerical value for comparison among groups.

  9. Waist Circumference [ Time Frame: Baseline, 2, 4, 8, and 12 weeks ]
    Patient's waist in cm will be measured.

  10. Non-HDL Cholesterol [ Time Frame: Baseline, 2, 4, 8, and 12 weeks ]
    Non-HDL cholesterol will be measured and reported in mg/dL.

  11. HDL Cholesterol [ Time Frame: Baseline, 2, 4, 8, and 12 weeks ]
    HDL cholesterol will be measured and reported in mg/dL.

  12. Triglycerides [ Time Frame: Baseline, 2, 4, 8, and 12 weeks ]
    Triglycerides will be measured and reported in mg/dL.

  13. Glucose [ Time Frame: Baseline, 2, 4, 8, and 12 weeks ]
    Glucose will be measured and reported in mg/dL.

  14. Insulin [ Time Frame: Baseline, 2, 4, 8, and 12 weeks ]
    Insulin will be measured and reported in µU/mL.

  15. Leptin [ Time Frame: Baseline, 2, 4, 8, and 12 weeks ]
    Leptin will be measured and reported in ng/mL.

  16. ALT [ Time Frame: Baseline, 2, 4, 8, and 12 weeks ]
    Leptin will be measured and reported in IU/L.

  17. AST [ Time Frame: Baseline, 2, 4, 8, and 12 weeks ]
    Leptin will be measured and reported in IU/L.

  18. LDH [ Time Frame: Baseline, 2, 4, 8, and 12 weeks ]
    LDH will be measured and reported in IU/L.

  19. CRP [ Time Frame: Baseline, 2, 4, 8, and 12 weeks ]
    CRP will be measured and reported in mg/L.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

  1. Subjects requiring narcotics or other pain medications,
  2. Subjects with known GERD (unless responsive to PPI therapy and on a stable dose), esophagitis, Barrett's esophagus or peptic stricture on endoscopy
  3. Subjects with previous upper gastrointestinal surgery
  4. Pregnancy
  5. Subjects with diabetes, neuromuscular disorders, cardiac disorders, or other severe co-morbidities (Cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic).
  6. Subjects with upper airway symptoms (such as hoarseness, wheezing or laryngospasm)
  7. Medications such as baclofen, sucralfate and prokinetic agents or any agent considered a sedative, hypnotic, or psychoactive drug.
  8. Known history of substance abuse.
  9. Subject unable to consent.
  10. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569073


Locations
Layout table for location information
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Investigators
Layout table for investigator information
Principal Investigator: 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

Layout table for additonal information
Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT02569073     History of Changes
Other Study ID Numbers: 22894
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Temple University:
Functional Chest Pain
Non-Cardiac Chest Pain
Esophageal Hypersensitivity

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