Trial Outcomes & Findings for Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis (NCT NCT05065567)

NCT ID: NCT05065567

Last Updated: 2025-05-21

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 32 participants
• Primary outcome timeframe: 2 hours
• Results posted on: 2025-05-21

Participant Flow

Participant milestones

Measure	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	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	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
Overall Study STARTED	11	14	7
Overall Study COMPLETED	1	5	1
Overall Study NOT COMPLETED	10	9	6

Reasons for withdrawal

Measure	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	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	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
Overall Study Lost to Follow-up	10	9	6

Baseline Characteristics

Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis

Baseline characteristics by cohort

Measure	Haloperidol n=11 Participants 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	Droperidol n=14 Participants 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	Ondansetron n=7 Participants 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	Total n=32 Participants Total of all reporting groups
Age, Continuous	32.45 years STANDARD_DEVIATION 8.56 • n=5 Participants	29.93 years STANDARD_DEVIATION 9.52 • n=7 Participants	27.57 years STANDARD_DEVIATION 9.52 • n=5 Participants	30.28 years STANDARD_DEVIATION 10.29 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	16 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	16 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	15 Participants n=4 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	15 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	11 participants n=5 Participants	14 participants n=7 Participants	7 participants n=5 Participants	32 participants n=4 Participants
Pain_Before_Medication	4.00 units on a scale: 0 through 10 STANDARD_DEVIATION 3.30 • n=5 Participants	3.38 units on a scale: 0 through 10 STANDARD_DEVIATION 3.04 • n=7 Participants	4.80 units on a scale: 0 through 10 STANDARD_DEVIATION 3.70 • n=5 Participants	3.86 units on a scale: 0 through 10 STANDARD_DEVIATION 3.17 • n=4 Participants
Nausea_Before_Medication	3.4 units on a scale: 0 through 10 STANDARD_DEVIATION 3.37 • n=5 Participants	3.69 units on a scale: 0 through 10 STANDARD_DEVIATION 2.50 • n=7 Participants	5.00 units on a scale: 0 through 10 STANDARD_DEVIATION 4.10 • n=5 Participants	3.86 units on a scale: 0 through 10 STANDARD_DEVIATION 3.11 • n=4 Participants

PRIMARY outcome

Timeframe: 2 hours

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

Outcome measures

Measure	Haloperidol n=10 Participants 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	Droperidol n=13 Participants 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	Ondansetron n=5 Participants 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
Abdominal Pain	4.00 score on a scale Standard Deviation 3.30	3.38 score on a scale Standard Deviation 3.04	4.8 score on a scale Standard Deviation 3.70

PRIMARY outcome

Timeframe: 2 hours

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

Outcome measures

Measure	Haloperidol n=10 Participants 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	Droperidol n=13 Participants 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	Ondansetron n=6 Participants 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
Nausea	3.40 score on a scale Standard Deviation 3.37	3.69 score on a scale Standard Deviation 2.50	5 score on a scale Standard Deviation 4.10

PRIMARY outcome

Timeframe: 24 hours

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

Outcome measures

Measure	Haloperidol n=1 Participants 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	Droperidol n=5 Participants 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	Ondansetron n=1 Participants 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
Abdominal Pain	5 score on a scale Standard Deviation NA Only 1 pt; cannot calculate SD	2.6 score on a scale Standard Deviation 3.71	3 score on a scale Standard Deviation NA Only 1 pt; cannot calculate SD

PRIMARY outcome

Timeframe: 24 hours

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

Outcome measures

Measure	Haloperidol n=1 Participants 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	Droperidol n=5 Participants 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	Ondansetron n=1 Participants 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
Nausea	3.0 score on a scale Standard Deviation NA Only 1 pt; cannot calculate SD	3.0 score on a scale Standard Deviation 3.67	7.0 score on a scale Standard Deviation NA Only 1 pt; cannot calculate SD

PRIMARY outcome

Timeframe: 48 hours

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

Outcome measures

Measure	Haloperidol n=1 Participants 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	Droperidol n=5 Participants 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	Ondansetron n=1 Participants 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
Abdominal Pain	0 score on a scale Standard Deviation NA Only 1 pt; cannot calculate SD	3.69 score on a scale Standard Deviation 4.10	2 score on a scale Standard Deviation NA Only 1 pt; cannot calculate SD

PRIMARY outcome

Timeframe: 48 hours

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

Outcome measures

Measure	Haloperidol n=1 Participants 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	Droperidol n=5 Participants 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	Ondansetron n=1 Participants 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
Nausea	0.5 score on a scale Standard Deviation NA Only 1 pt; cannot calculate SD	3.2 score on a scale Standard Deviation 3.42	1 score on a scale Standard Deviation NA Only 1 pt; cannot calculate SD

SECONDARY outcome

Timeframe: 2 hours

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

Outcome measures

Measure	Haloperidol n=11 Participants 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	Droperidol n=14 Participants 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	Ondansetron n=7 Participants 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
Treatment Success	2 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 24 hours

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

Outcome measures

Measure	Haloperidol n=1 Participants 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	Droperidol n=5 Participants 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	Ondansetron n=1 Participants 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
Treatment Success	0 Participants	3 Participants	0 Participants

SECONDARY outcome

Timeframe: 48 hours

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

Outcome measures

Measure	Haloperidol n=1 Participants 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	Droperidol n=5 Participants 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	Ondansetron n=1 Participants 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
Treatment Success	1 Participants	2 Participants	1 Participants

Adverse Events

Haloperidol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Droperidol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ondansetron

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research Specialist

SpectrumLakeland

Phone: (240)389-7340

Email: rachelle.pichot@corewellhealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place