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Comparing Haloperidol to Olanzapine in the Treatment of Suspected Cannabinoid Hyperemesis in the Emergency Department

ConditionCannabinoid Hyperemesis Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorMercy Bon Secours Saint Vincent Medical Center

About this trial

The aim of the study is to identify which medication (haloperidol or olanzapine) is most effective in treating nausea and abdominal pain associated with cannabinoid hyperemesis using a 10-point visual analog scale with intervals of 0.5.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

subjects must meet ONE of the below criteria AND are a near-daily to daily user of cannabis by inhalation for greater than or equal to 6 months.

Have documented previous diagnosis of cannabinoid hyperemesis, or

Report (or on chart review) greater than or equal to 3 episodes of emesis in a cyclic pattern separated by greater than 1 month during the preceding 2 years, or

The provider suspects cannabinoid hyperemesis as the primary or equally likely primary diagnosis.

Disqualifiers

Ineligible subjects include age less than 18 years, weight less than 50 kg, pregnancy, daily benzodiazepines use, prolonged QTc interval on the electrocardiogram (ECG), breastfeeding mothers, previously known allergy to or intolerance of either study drug, subjects taking drugs that are contraindicated with haloperidol or olanzapine, subjects with Parkison's Disease, subjects already taking haloperidol, olanzapine, or other antipsychotics

Trial design

Design model

Single group

Treatments tested in this trial

  • Olanzapine 10 milligram

    Drug

    olanzapine 10 mg IM

  • Haloperidol

    Drug

    Haloperidol 5 mg IM

Treatment groups

114 Participants
are divided into 2 treatment groups
Group A: Haloperidol armActive comparator 1 intervention
Group B: Olanzapine armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Nausea VAS scale

nausea symptoms on a scale of 0-10 with 0 being no nausea and 10 being the worst nausea

Time frame
Change from Baseline nausea before medication administration to 60-120 minutes after medication administration
2

vomiting

vomiting symptoms on a scale of 0-10 with 0 being no vomiting and 10 being the worst vomiting

Time frame
Change from Baseline vomiting before medication administration to 60-120 minutes after medication administration
3

abdominal pain

VAS scale abdominal pain symptoms on a scale of 0-10 with 0 being no abdominal pain and 10 being the worst abdominal pain

Time frame
Change from Baseline abdominal pain before medication administration to 60-120 minutes after medication administration

Secondary outcomes

1

admission versus discharge

admission versus discharge

Time frame
Admission versus discharge status to be determined after the patient has been reassessed for their post medication nausea, vomiting, and abdominal pain VAS score. This occurs 60-120 minutes after study drug administration.
2

Ability to tolerate PO

Ability to tolerate liquids by mouth, the unit is binary, yes or no

Time frame
60-120 minutes after medication administration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mercy Bon Secours Saint Vincent Medical Center

Lead sponsor

Source ClinicalTrials.gov
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