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Cannabinoid

Dranabinol Capsules for Nausea

Phase 2
Waitlist Available
Led By Horacio C Kaufmann, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
All Individual Drugs Already Approved

Summary

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.

Eligible Conditions
  • Nausea
  • Vomiting
  • Familial Dysautonomia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in nausea scores
Number of adverse effects
Secondary study objectives
Change in anxiety scores
Change in weight.

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dranabinol CapsulesExperimental Treatment1 Intervention
The initial dose will be 2.5 mg BID (5 mg/day), and the maximum dose will be 10 mg TID (30 mg/day).
Group II: Placebo CapsulesPlacebo Group1 Intervention
placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dronabinol
FDA approved

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,403 Previous Clinical Trials
855,126 Total Patients Enrolled
1 Trials studying Nausea
159 Patients Enrolled for Nausea
Horacio C Kaufmann, MDPrincipal InvestigatorNYU MEDICAL CENTER
3 Previous Clinical Trials
988 Total Patients Enrolled
~0 spots leftby Oct 2025