Haloperidol Versus Ondansetron for Cannabis Hyperemesis Syndrome (HaVOC)

NCT03056482 | Completed Phase 4 DMC

• 1 other identifier: EMED-251-17
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief 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. 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

Conditions

Cannabis Use Disorder

Keywords

cannabis; haloperidol; ondansetron; hyperemesis; cyclic vomiting syndrome

Outcome Measures

Primary Outcomes (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

  2 hours

Secondary Outcomes (13)

• Change in pain

  1, 2, 24 and 48 hours

• Change in nausea

  1, 2, 24 and 48 hours

• Treatment success

  2, 24 and 48 hours

• Oral intake

  2 hours

• Emesis volume

  2 hours

Study Arms (3)

Ondansetron 8mg

ACTIVE COMPARATOR

8mg Ondansetron prepared in a 100mL normal saline mini-bag

Drug: Ondansetron 8mg

Haloperidol 0.05mg/kg

EXPERIMENTAL

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

Drug: Haloperidol 0.05mg/kg

Haloperidol 0.1mg/kg

EXPERIMENTAL

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

Drug: Haloperidol 0.1mg/kg

Interventions

Ondansetron 8mg DRUG

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

Also known as: Zofran

Ondansetron 8mg

Haloperidol 0.05mg/kg DRUG

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

Also known as: Haldol

Haloperidol 0.05mg/kg

Haloperidol 0.1mg/kg DRUG

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

Also known as: Haldol

Haloperidol 0.1mg/kg

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Marco L.A. Sivilotti: lead

Study Sites (3)

Hotel Dieu Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Related Publications (1)

• 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.

  PMID: 33160719 DERIVED

MeSH Terms

Conditions

Marijuana Abuse; Hyperemesis Gravidarum; Familial cyclic vomiting syndrome

Interventions

Ondansetron; Haloperidol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Morning Sickness; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vomiting; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Butyrophenones; Ketones; Organic Chemicals

Study Officials

• Marco LA Sivilotti, MD, MSc

  Dept. of Emergency Medicine, Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be allocated to an intervention via a sealed, opaque envelope system to be opened by an unblinded nurse not otherwise involved in patient care or research procedures will prepare the intervention. The Attending physician, Research personnel and Investigator(s) will all remain blinded to the allocation.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: February 17, 2017
• Study Start: May 21, 2017
• Primary Completion: June 30, 2019
• Study Completion: July 7, 2019
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)