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Cannabis Use DisorderPhase 4HaVOCNCT03056482

Haloperidol Versus Ondansetron for Cannabis Hyperemesis Syndrome (HaVOC)

A Phase 4 study testing Ondansetron 8mg, Haloperidol 0.05mg/kg and Haloperidol 0.1mg/kg in people with Cannabis Use Disorder, run by Dr. Marco L.A. Sivilotti at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cannabis Hyperemesis Syndrome (CHS) has become a well-documented syndrome since 2004 and is expected to increase in prevalence with continuing liberalization of marijuana and recognition of the disease. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Cannabis Use Disorder
What is being tested?
Ondansetron 8mg, Haloperidol 0.05mg/kg and Haloperidol 0.1mg/kg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
3 sitesCanada
Study dates
21 May 2017to 7 Jul 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > 18 years
  • Self-report of ≥3 episodes of emesis occurring in a cyclic pattern for greater than 1 month in the preceding 2 years
  • Current episode >2 hours of emesis
  • At least one episode of emesis/forceful retching witnessed (including products of emesis at bedside) or heard by an independent observer (healthcare provider or family/friend) in the emergency department
  • Self-reported frequent (near daily to daily x at least 6 months) use of cannabis by inhalation.
  • Working diagnosis of cannabis hyperemesis syndrome in the opinion of the treating emergency physician

Who cannot join

  • Chronic, daily use of opioid equivalent to ≥10mg morphine/day
  • Inability to comprehend study consent or instructions
  • Unreliable follow-up/unlikely to return for cross-over
  • Administration of an intravenous antiemetic, anticholinergic or antipsychotic (other than up to 100mg dimenhydrinate) in the previous 24 hours
  • Allergy or intolerance to haloperidol or ondansetron
  • Pregnancy
  • Any other medical or psychiatric condition that in the opinion of the enrolling physician would interfere with participation in the trial
  • Current active participation in an investigational drug trial

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Hotel Dieu Hospital

    Kingston, Ontario, K7L 2V7

  • Kingston General Hospital

    Kingston, Ontario, K7L 2V7

  • Queen's University

    Kingston, Ontario, K7L 3N6

Other trials in Canada

About this study

Official title: Haloperidol Versus Ondansetron for Cannabis Hyperemesis Syndrome (HaVOC): A Randomized Controlled Trial

Cannabis Hyperemesis Syndrome (CHS) has become a well-documented syndrome since 2004 and is expected to increase in prevalence with continuing liberalization of marijuana and recognition of the disease. Regardless of whether the association with heavy cannabis use is recognized, there is well-documented resistance to traditional anti-emetic treatment. Given promising reports of the use of intravenous haloperidol, a randomized controlled trial comparing it to the commonly administered anti-emetic ondansetron will contribute to the management of CHS

Read the detailed description

This is a double-blinded, randomized, cross-over clinical trial that will enroll approximately 80 subjects from at least four different research sites. Patients who have been diagnosed with CHS and enrolled in our study will act as their own controls upon their return to the ED for a subsequent bout of CHS for up to 3 visits per subject. Each patient will be allocated in a 1:1:1 fashion into one of three treatment groups: high- or low-dose haloperidol, or ondansetron, with a minimum 7-day washout period between treatments. As CHS tends to be a recurrent syndrome (presumably given the continued use of cannabis despite recommendations to taper and abstain), it is expected that most subjects will return at least once again, and a substantial subset of the study population will complete all three treatment visits during the trial.

Being tested
Ondansetron 8mg, Haloperidol 0.05mg/kg, Haloperidol 0.1mg/kg
Keywords
cannabis, haloperidol, ondansetron, hyperemesis, cyclic vomiting syndrome
Medical subject headings
Marijuana Abuse, Hyperemesis Gravidarum, Familial cyclic vomiting syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ondansetron 8mgDrug

    Also called Zofran

    Ondansetron 8 MG prepared in a 100 mL normal saline min-bag

  • Haloperidol 0.05mg/kgDrug

    Also called Haldol

    Haloperidol 0.05 mg/kg prepared in a 100 mL normal saline min-bag

  • Haloperidol 0.1mg/kgDrug

    Also called Haldol

    Haloperidol 0.1 mg/kg prepared in a 100 mL normal saline min-bag

Study groups in NCT03056482
Study groupRoleWhat they receive
Ondansetron 8mgActive comparator8mg Ondansetron prepared in a 100mL normal saline mini-bag
Receives: Drug: Ondansetron 8mg
Haloperidol 0.05mg/kgExperimental0.05mg/kg of Haloperidol prepared in a 100mL normal saline mini-bag
Receives: Drug: Haloperidol 0.05mg/kg
Haloperidol 0.1mg/kgExperimental0.1mg/kg of Haloperidol prepared in a 100mL normal saline mini-bag
Receives: Drug: Haloperidol 0.1mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in pain and nausea

    Difference between arithmetic mean of Pain Score and Nausea Score (each on a 10-cm VAS) at 2 hours versus at baseline

    Measured: 2 hours

Secondary outcomes (13)

  1. Change in pain

    Changes in abdominal pain score at 1, 2, 24 and 48 hours vs. baseline

    Measured: 1, 2, 24 and 48 hours

  2. Change in nausea

    Changes in nausea score at 1, 2, 24 and 48 hours vs. baseline

    Measured: 1, 2, 24 and 48 hours

  3. Treatment success

    Treatment success = both abdominal pain and nausea score < 2 at 2, 24 and 48 hours

    Measured: 2, 24 and 48 hours

  4. Oral intake

    Cumulative oral intake from t=0 to 2 hours (in mL)

    Measured: 2 hours

  5. Emesis volume

    Cumulative emesis from t=0 to 2 hours (in mL)

    Measured: 2 hours

  6. Urine output

    Cumulative urine output (in mL)

    Measured: 2 hours

  7. Discharge ready at 2 hours

    Deemed discharge-ready at 2 hours in the opinion of the treating physician

    Measured: 2 hours

  8. Rescue anti-emetics in ED

    Given rescue anti-emetics prior to discharge

    Measured: at discharge from Emergency Department or 12 hours whichever comes first

  9. Time to discharge from ED

    Time interval to discharge-ready from t=0 (min)

    Measured: at discharge from Emergency Department or 12 hours whichever comes first

  10. Subject preferred arm

    Subject preference of high- vs low-dose haloperidol, and of haloperidol vs ondansetron (-10, 10)

    Measured: 2 hours

  11. Return to ED

    Unscheduled return visits to ED within 7 days (count)

    Measured: 7 days

  12. ED consult

    Consulted to admitting service

    Measured: From time of study intervention until admitting service consulted or subject discharged from Emergency Department, whichever comes first, assessed up to 48 hours

  13. Prolonged ED Length of stay

    Outcome 10 "Time to Discharge from ED" > 12 hours (binary yes/no)

    Measured: at discharge from Emergency Department or 12 hours whichever comes first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2017
  2. Study start21 May 2017
  3. Primary completion30 Jun 2019
  4. Study completion7 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
This is a double-blinded, randomized, cross-over clinical trial that will allocate subjects in a 1:1:1 fashion into one of three treatment groups: high- or low-dose haloperidol, or ondansetron, with a minimum 7-day washout period between treatments.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03056482
Sponsor's protocol ID
EMED-251-17
Acronym
HaVOC
Status last verified
Apr 2024
First submitted
23 Jan 2017
Last updated
3 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ruberto AJ, Sivilotti MLA, Forrester S, Hall AK, Crawford FM, Day AG. Intravenous Haloperidol Versus Ondansetron for Cannabis Hyperemesis Syndrome (HaVOC): A Randomized, Controlled Trial. Ann Emerg Med. 2021 Jun;77(6):613-619. doi: 10.1016/j.annemergmed.2020.08.021. Epub 2020 Nov 5.

    PubMed 33160719

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ondansetron 8mg, Haloperidol 0.05mg/kg and Haloperidol 0.1mg/kg in people with Cannabis Use Disorder, run by Dr. Marco L.A. Sivilotti at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain and nausea (time frame: 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03056482, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.

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