Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis

NCT ID: NCT05065567

Last Updated: 2025-05-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-30

Study Completion Date

2023-11-20

Brief Summary

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The purpose of this study is to compare two commonly used agents for the treatment of cyclic vomiting to see if one agent is inferior to the other in time to improvement in symptoms, need for repeat or rescue medications, treatment failures and complications/side effects.

Detailed Description

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Conditions

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Cyclic Vomiting Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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haloperidol

these patients will receive 5mg IM haloperidol

Group Type ACTIVE_COMPARATOR

Haloperidol

Intervention Type DRUG

Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM

droperidol

these patients will receive 2.5mg IV droperidol

Group Type ACTIVE_COMPARATOR

Droperidol

Intervention Type DRUG

Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV

ondansetron

these patients will receive 8mg IV ondansetron

Group Type ACTIVE_COMPARATOR

Ondansetron 8mg

Intervention Type DRUG

Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron

Interventions

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Droperidol

Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV

Intervention Type DRUG

Haloperidol

Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM

Intervention Type DRUG

Ondansetron 8mg

Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients with clinical diagnosis of cyclic vomiting in the ED

Exclusion Criteria

* pregnancy, allergy to any of the study medicines
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spectrum Health - Lakeland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lakeland Regional Healthcare

Saint Joseph, Michigan, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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EGME#02-2021

Identifier Type: -

Identifier Source: org_study_id

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