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Not yet recruiting NCT07726069

Haloperidol For Outpatient Symptom Management in Patients Diagnosed With Cannabinoid Hyperemesis Syndrome in the Emergrency Department

Early Phase I Interventional Cannabinoid Hyperemesis Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Haloperidol.
Who it may be relevant to
Registry conditions: Cannabinoid Hyperemesis Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Patients diagnosed with cannabinoid hyperemesis syndrome that are safe for discharge from the emergency department will be sent an outpatient prescription for haloperidol to be used as needed at home. The study goal is to see if having this medication available helps to prevent return emergency department visits for recurrent or persistent symptoms.

Detailed description

Cannabinoid hyperemesis syndrome is a relatively new syndrome characterized by nausea, vomiting, and abdominal pain in the setting of excessive cannabis use. This clinical entity has become increasingly prevalent as the concentration of THC has increased in marijuana products over the past several decades. The symptoms have been treated successfully with several medications however the most efficacious appears to be dopamine antagonists such as haloperidol and droperidol. These dopamine antagonists have been used safely and successfully in the inpatient and emergency department settings to decrease the frequency and intensity of nausea, vomiting, and abdominal pain in patients suffering from cannabinoid hyperemesis syndrome. We plan to evaluate haloperidol, a dopamine antagonist available as an oral formulation, as an option for outpatient management of these symptoms.

Interventions

  • Drug Haloperidol
    This intervention involves providing patients an outpatient prescription for as needed haloperidol to attempt to control symptoms of cannabinoid hyperemesis and to attempt to prevent return to the emergency department for that reason.

Primary outcome measures

  • Rate of return to the emergency department [Time frame: 1 month]
Secondary outcome measures (2)
  • Improvement in symptoms [Time frame: 1 month]
  • Medication side effects [Time frame: 1 month]

Eligibility criteria

Inclusion criteria

  • Patients who meet ROME-4 diagnostic criteria for cannabinoid hyperemesis syndrome

Exclusion criteria

Already on dopamine agonist/antagonist therapy for another condition Parkinson's disease Lewy body dementia Men with QTc > 450 Women with QTc > 460 Patients with documented allergy to haloperidol Patients with known functional prolactinomas Patients who are breastfeeding Patients under the age of 18 Patients who are pregnant Patients who are in the prison system Patients who are unable to consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Illinois Hospital — Chicago

Identifiers

NCT: NCT07726069 · 2026-0693

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗