Nausea Clinical Trial
Official title:
The Safety , Tolerability and Efficacy of Dronabinol, a Synthetic Endocannabinoid Receptor Agonist, for the Treatment of Nausea and Vomiting in Patients With Familial Dysautonomia
This is a pilot clinical trial of dronabinol to treat disabling attacks of nausea and vomiting in patients with familial dysautonomia (FD, also known as Riley Day syndrome or hereditary sensory and autonomic neuropathy type III). FD is a rare autosomal recessive disease in which the growth and development of selective nerves is impaired. Patients with FD suffer recurrent uncontrollable nausea and vomiting crises accompanied by skin flushing, tachycardia and arterial hypertension. Current treatments of nausea are ineffective or have intolerable side sides. Our long-term goal is to treat nausea effectively and without side effects, a therapeutic intervention that would markedly improve the quality of life of patients with FD.
The purpose of this pilot study is to assess the safety, tolerability and efficacy of
dronabinol for the treatment of nausea in patients with FD. The pilot trial will recruit 25
patients with FD who complain of severe nausea that affects their quality of life. The trial
will be divided into two consecutive, but independent parts. Part 1, will address the safety
and tolerability of dronabinol in patients with FD using an open-label dose titration phase
followed by 4-weeks of wash-out period. Part 2 will address the efficacy of dronabinol for
the treatment of nausea in patients with FD using a randomized, placebo controlled, double
blind, 12-week cross over design.
The first specific aim of this proposal is to assess the safety and tolerability of
dronabinol in patients with FD. The second specific aim of this proposal is to determine
whether stimulation of endocannabinoid receptors with dronabinol will improve recurrent
nausea in patients with FD. Secondary aims are to determine whether stimulation of
endocannabinoid receptors with dronabinol will increase weight, and decrease anxiety.
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