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TerminatedNCT05065567Updated May 21, 2025Results posted

Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis

A Phase 3 interventional study of Droperidol and Haloperidol in Cyclic Vomiting Syndrome, sponsored by Spectrum Health - Lakeland. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-21.

Sponsored by Spectrum Health - Lakeland · Phase 3, Interventional, and Treatment

Why this study was terminated
Lost too many patients to follow up, unable to enroll enough patients
Phase
Phase 3
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cyclic Vomiting Syndrome
03

In context

Hyperemesis Gravidarum

45 studies on the registry are indexed under Hyperemesis Gravidarum; 7 are open to participants now.

This study's enrollment of 32 is below the median of 75 across 28 interventional studies indexed under Hyperemesis Gravidarum.

Browse Hyperemesis Gravidarum studies →

Lead sponsor

Spectrum Health - Lakeland is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • pregnancy, allergy to any of the study medicines
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
32 participants (actual)

Study arms

  • Active comparator
    haloperidol

    these patients will receive 5mg IM haloperidol

    Drug: Haloperidol

  • Active comparator
    droperidol

    these patients will receive 2.5mg IV droperidol

    Drug: Droperidol

  • Active comparator
    ondansetron

    these patients will receive 8mg IV ondansetron

    Drug: Ondansetron 8mg

Interventions

  • DrugDroperidol

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

  • DrugHaloperidol

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

  • DrugOndansetron 8mg

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

06

What researchers measure

Primary outcomes

  1. Abdominal Pain

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

    Time frame: 2 hours

  2. Nausea

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

    Time frame: 2 hours

  3. Abdominal Pain

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

    Time frame: 24 hours

  4. Nausea

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

    Time frame: 24 hours

  5. Abdominal Pain

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

    Time frame: 48 hours

  6. Nausea

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

    Time frame: 48 hours

Secondary outcomes

  1. Treatment Success

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

    Time frame: 2 hours

  2. Treatment Success

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

    Time frame: 24 hours

  3. Treatment Success

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

    Time frame: 48 hours

07

Results

Posted May 21, 2025
Limitations and caveats
Limitations: This study was terminated as the researchers were unable to enroll enough patients and too many patients were lost to follow up.

Participant flow

Participant flow — Overall Study
MilestoneHaloperidolDroperidolOndansetron
Started11147
Completed151
Not completed1096
Withdrew: Lost to follow-up1096

Outcome measures

PrimaryAbdominal Pain

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

Time frame:
2 hours
Reported as:
Mean · score on a scale
Abdominal Pain
score on a scaleHaloperidolDroperidolOndansetron
Abdominal Pain4.00 ± 3.303.38 ± 3.044.8 ± 3.70
PrimaryNausea

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

Time frame:
2 hours
Reported as:
Mean · score on a scale
Nausea
score on a scaleHaloperidolDroperidolOndansetron
Nausea3.40 ± 3.373.69 ± 2.505 ± 4.10
SecondaryTreatment Success

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

Time frame:
2 hours
Reported as:
Count of participants · Participants
Treatment Success
ParticipantsHaloperidolDroperidolOndansetron
Treatment Success231
PrimaryAbdominal Pain

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

Time frame:
24 hours
Reported as:
Mean · score on a scale
Abdominal Pain
score on a scaleHaloperidolDroperidolOndansetron
Abdominal Pain5 ± NA2.6 ± 3.713 ± NA
PrimaryNausea

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

Time frame:
24 hours
Reported as:
Mean · score on a scale
Nausea
score on a scaleHaloperidolDroperidolOndansetron
Nausea3.0 ± NA3.0 ± 3.677.0 ± NA
PrimaryAbdominal Pain

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

Time frame:
48 hours
Reported as:
Mean · score on a scale
Abdominal Pain
score on a scaleHaloperidolDroperidolOndansetron
Abdominal Pain0 ± NA3.69 ± 4.102 ± NA
PrimaryNausea

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

Time frame:
48 hours
Reported as:
Mean · score on a scale
Nausea
score on a scaleHaloperidolDroperidolOndansetron
Nausea0.5 ± NA3.2 ± 3.421 ± NA
SecondaryTreatment Success

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

Time frame:
24 hours
Reported as:
Count of participants · Participants
Treatment Success
ParticipantsHaloperidolDroperidolOndansetron
Treatment Success030
SecondaryTreatment Success

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

Time frame:
48 hours
Reported as:
Count of participants · Participants
Treatment Success
ParticipantsHaloperidolDroperidolOndansetron
Treatment Success121

Adverse events

Collected over 48 hours from drug administration.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Haloperidol0/11 (0%)0/11 (0%)0/11 (0%)
Droperidol0/14 (0%)0/14 (0%)0/14 (0%)
Ondansetron0/7 (0%)0/7 (0%)0/7 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)HaloperidolDroperidolOndansetronTotal
Mean32.45 ± 8.5629.93 ± 9.5227.57 ± 9.5230.28 ± 10.29
Sex: Female, Male
Sex: Female, Male(Participants)HaloperidolDroperidolOndansetronTotal
Female29516
Male95216
Race (NIH/OMB)
Race (NIH/OMB)(Participants)HaloperidolDroperidolOndansetronTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American57315
White56415
More than one race0000
Unknown or Not Reported1102
Region of Enrollment
Region of Enrollment(participants)HaloperidolDroperidolOndansetronTotal
United States1114732
Pain_Before_Medication
Pain_Before_Medication(units on a scale: 0 through 10)HaloperidolDroperidolOndansetronTotal
Mean4.00 ± 3.303.38 ± 3.044.80 ± 3.703.86 ± 3.17
Nausea_Before_Medication
Nausea_Before_Medication(units on a scale: 0 through 10)HaloperidolDroperidolOndansetronTotal
Mean3.4 ± 3.373.69 ± 2.505.00 ± 4.103.86 ± 3.11
08

Study locations

1 site
  • Lakeland Regional Healthcare
    Saint Joseph, Michigan 49085, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · May 19, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05065567
Lead sponsor
Spectrum Health - Lakeland
Responsible party
Sponsor
First posted
Oct 4, 2021
Start date
Aug 30, 2021
Primary completion
Nov 20, 2023
Completion
Nov 20, 2023
Results posted
May 21, 2025
Last update
May 21, 2025

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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