Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis | NCT05065567

Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis | NCT05065567 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
haloperidol	Active Comparator	these patients will receive 5mg IM haloperidol	Drug: Haloperidol
droperidol	Active Comparator	these patients will receive 2.5mg IV droperidol	Drug: Droperidol
ondansetron	Active Comparator	these patients will receive 8mg IV ondansetron	Drug: Ondansetron 8mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Droperidol	Drug	Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV	droperidol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Abdominal Pain	change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale	2 hours
Nausea	change in nausea on 0 (none) through 10 (worse possible nausea) on a scale	2 hours
Abdominal Pain	change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale	24 hours
Nausea	change in nausea on 0 (none) through 10 (worse possible nausea) on a scale	24 hours
Abdominal Pain	change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale	48 hours
Nausea	change in nausea on 0 (none) through 10 (worse possible nausea) on a scale	48 hours

Secondary Outcomes

Measure	Description	Time Frame
Treatment Success	both abdominal pain and nausea scores under 2 (none or minimal)	2 hours
Treatment Success	both abdominal pain and nausea scores under 2 (none or minimal)

Facility	Status	City	State	ZIP	Country	Contacts
Lakeland Regional Healthcare		Saint Joseph	Michigan	49085	United States

Arm/Group Information

ID	Title	Description
FG000	Haloperidol	these patients will receive 5mg IM haloperidol Haloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM
FG001	Droperidol	these patients will receive 2.5mg IV droperidol Droperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV
FG002	Ondansetron	these patients will receive 8mg IV ondansetron Ondansetron 8mg: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00011 subjects FG00114 subjects FG0027 subjects
COMPLETED		FG0001 subjects FG0015 subjects FG0021 subjects
NOT COMPLETED		FG00010 subjects FG0019 subjects FG0026 subjects

Type	Comment	Reasons
Lost to Follow-up		FG00010 subjects FG0019 subjects FG0026 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Haloperidol	these patients will receive 5mg IM haloperidol Haloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM
BG001	Droperidol

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Abdominal Pain

change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale

Posted

Mean

Standard Deviation

score on a scale

2 hours

ID	Title	Description
OG000	Haloperidol	these patients will receive 5mg IM haloperidol Haloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM
OG001	Droperidol	these patients will receive 2.5mg IV droperidol Droperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Haloperidol	these patients will receive 5mg IM haloperidol Haloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Research Specialist	SpectrumLakeland	(240)389-7340		rachelle.pichot@corewellhealth.org

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	May 19, 2025	May 19, 2025	Prot_SAP_002.pdf

ID	Term
C536228	Familial cyclic vomiting syndrome

Intervention Browse Module

ID	Term
D004329	Droperidol
D006220	Haloperidol
D017294	Ondansetron

ID	Term
D002090	Butyrophenones
D007659	Ketones
D009930	Organic Chemicals
D001562	Benzimidazoles

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG0020 BG0030
Asian	BG0000 BG0010 BG0020 BG0030
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020 BG0030
Black or African American	BG0005 BG0017 BG0023 BG00315
White	BG0005 BG0016 BG0024 BG00315
More than one race	BG0000 BG0010 BG0020 BG0030
Unknown or Not Reported	BG0001 BG0011 BG0020 BG0032

Primary

Nausea

change in nausea on 0 (none) through 10 (worse possible nausea) on a scale

Posted

Mean

Standard Deviation

score on a scale

2 hours

ID	Title	Description
OG000	Haloperidol	these patients will receive 5mg IM haloperidol Haloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM
OG001	Droperidol	these patients will receive 2.5mg IV droperidol Droperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV
OG002	Ondansetron	these patients will receive 8mg IV ondansetron Ondansetron 8mg: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron

Units	Counts
Participants	OG00010 OG00113 OG0026

Title

Denominators

Categories

Title	Measurements
	OG0003.40± 3.37 OG0013.69± 2.50 OG0025± 4.10

Secondary

Treatment Success

both abdominal pain and nausea scores under 2 (none or minimal)

Posted

Count of Participants

Participants

2 hours

ID	Title	Description
OG000	Haloperidol	these patients will receive 5mg IM haloperidol Haloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM
OG001	Droperidol	these patients will receive 2.5mg IV droperidol Droperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV
OG002	Ondansetron	these patients will receive 8mg IV ondansetron Ondansetron 8mg: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron

Units	Counts
Participants	OG00011 OG00114 OG0027

Title

Denominators

Categories

Title	Measurements
	OG0002 OG0013 OG0021

Primary

Abdominal Pain

change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale

Posted

Mean

Standard Deviation

score on a scale

24 hours

ID	Title	Description
OG000	Haloperidol	these patients will receive 5mg IM haloperidol Haloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM
OG001	Droperidol	these patients will receive 2.5mg IV droperidol Droperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV
OG002	Ondansetron	these patients will receive 8mg IV ondansetron Ondansetron 8mg: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron

Units	Counts
Participants	OG0001 OG0015 OG0021

Title

Denominators

Categories

Title	Measurements
	OG0005± NAOnly 1 pt; cannot calculate SD OG0012.6± 3.71 OG0023± NAOnly 1 pt; cannot calculate SD

Primary

Nausea

change in nausea on 0 (none) through 10 (worse possible nausea) on a scale

Posted

Mean

Standard Deviation

score on a scale

24 hours

ID	Title	Description
OG000	Haloperidol	these patients will receive 5mg IM haloperidol Haloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM
OG001	Droperidol	these patients will receive 2.5mg IV droperidol Droperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV
OG002	Ondansetron	these patients will receive 8mg IV ondansetron Ondansetron 8mg: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron

Units	Counts
Participants	OG0001 OG0015 OG0021

Title

Denominators

Categories

Title	Measurements
	OG0003.0± NAOnly 1 pt; cannot calculate SD OG0013.0± 3.67 OG0027.0± NAOnly 1 pt; cannot calculate SD

Primary

Abdominal Pain

change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale

Posted

Mean

Standard Deviation

score on a scale

48 hours

ID	Title	Description
OG000	Haloperidol	these patients will receive 5mg IM haloperidol Haloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM
OG001	Droperidol	these patients will receive 2.5mg IV droperidol Droperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV
OG002	Ondansetron	these patients will receive 8mg IV ondansetron Ondansetron 8mg: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron

Units	Counts
Participants	OG0001 OG0015 OG0021

Title

Denominators

Categories

Title	Measurements
	OG0000± NAOnly 1 pt; cannot calculate SD OG0013.69± 4.10 OG0022± NAOnly 1 pt; cannot calculate SD

Primary

Nausea

change in nausea on 0 (none) through 10 (worse possible nausea) on a scale

Posted

Mean

Standard Deviation

score on a scale

48 hours

ID	Title	Description
OG000	Haloperidol	these patients will receive 5mg IM haloperidol Haloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM
OG001	Droperidol	these patients will receive 2.5mg IV droperidol Droperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV
OG002	Ondansetron	these patients will receive 8mg IV ondansetron Ondansetron 8mg: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron

Units	Counts
Participants	OG0001 OG0015 OG0021

Title

Denominators

Categories

Title	Measurements
	OG0000.5± NAOnly 1 pt; cannot calculate SD OG0013.2± 3.42 OG0021± NAOnly 1 pt; cannot calculate SD

Secondary

Treatment Success

both abdominal pain and nausea scores under 2 (none or minimal)

Posted

Count of Participants

Participants

24 hours

ID	Title	Description
OG000	Haloperidol	these patients will receive 5mg IM haloperidol Haloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM
OG001	Droperidol	these patients will receive 2.5mg IV droperidol Droperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV
OG002	Ondansetron	these patients will receive 8mg IV ondansetron Ondansetron 8mg: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron

Units	Counts
Participants	OG0001 OG0015 OG0021

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0013 OG0020

Secondary

Treatment Success

both abdominal pain and nausea scores under 2 (none or minimal)

Posted

Count of Participants

Participants

48 hours

ID	Title	Description
OG000	Haloperidol	these patients will receive 5mg IM haloperidol Haloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM
OG001	Droperidol	these patients will receive 2.5mg IV droperidol Droperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV
OG002	Ondansetron	these patients will receive 8mg IV ondansetron Ondansetron 8mg: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron

Units	Counts
Participants	OG0001 OG0015 OG0021

Title

Denominators

Categories

Title	Measurements
	OG0001 OG0012 OG0021