Dronabinol
Dronabinol 5 mg, every other night, orally
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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2019-09-26
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
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.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Dronabinol 5 mg, every other night, orally
MarinolPlacebo--no drug
Eligibility
primary outcomes
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 outcomes
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.
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.
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
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
Time frame: Baseline, 2, 4, 8, and 12 weeks
Analysis of depressive symptoms normalized to a numerical value for comparison among groups.
Time frame: Baseline, 2, 4, 8, and 12 weeks
Total cholesterol will be measured and reported in mg/dL.
Time frame: Baseline, 2, 4, 8, and 12 weeks
Patient mass will be measured in kg.
Time frame: Baseline, 2, 4, 8, and 12 weeks
Analysis of anxious symptoms normalized to a numerical value for comparison among groups.
Time frame: Baseline, 2, 4, 8, and 12 weeks
Patient's waist in cm will be measured.
Time frame: Baseline, 2, 4, 8, and 12 weeks
Non-HDL cholesterol will be measured and reported in mg/dL.
Time frame: Baseline, 2, 4, 8, and 12 weeks
HDL cholesterol will be measured and reported in mg/dL.
Time frame: Baseline, 2, 4, 8, and 12 weeks
Triglycerides will be measured and reported in mg/dL.
Time frame: Baseline, 2, 4, 8, and 12 weeks
Glucose will be measured and reported in mg/dL.
Time frame: Baseline, 2, 4, 8, and 12 weeks
Insulin will be measured and reported in µU/mL.
Time frame: Baseline, 2, 4, 8, and 12 weeks
Leptin will be measured and reported in ng/mL.
Time frame: Baseline, 2, 4, 8, and 12 weeks
Leptin will be measured and reported in IU/L.
Time frame: Baseline, 2, 4, 8, and 12 weeks
Leptin will be measured and reported in IU/L.
Time frame: Baseline, 2, 4, 8, and 12 weeks
LDH will be measured and reported in IU/L.
Time frame: Baseline, 2, 4, 8, and 12 weeks
CRP will be measured and reported in mg/L.
Publications
No exact PMID-linked public article is currently readable locally.