Haloperidol Versus Ondansetron for Cannabis Hyperemesis Syndrome (HaVOC)

Cannabis Use Disorder Clinical Trial

— HaVOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03056482
• Other study ID #: EMED-251-17
• Status: Completed
• Phase: Phase 4
• Start date: May 21, 2017
• Est. completion date: July 7, 2019

Study information

• Verified date: April 2024
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 7, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Age > 18 years

2. Self-report of =3 episodes of emesis occurring in a cyclic pattern for greater than 1 month in the preceding 2 years

3. Current episode >2 hours of emesis

4. 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

5. Self-reported frequent (near daily to daily x at least 6 months) use of cannabis by inhalation.

6. Working diagnosis of cannabis hyperemesis syndrome in the opinion of the treating emergency physician

Exclusion Criteria:

1. Chronic, daily use of opioid equivalent to =10mg morphine/day

2. Inability to comprehend study consent or instructions

3. Unreliable follow-up/unlikely to return for cross-over

4. Administration of an intravenous antiemetic, anticholinergic or antipsychotic (other than up to 100mg dimenhydrinate) in the previous 24 hours

5. Allergy or intolerance to haloperidol or ondansetron

6. Pregnancy

7. Any other medical or psychiatric condition that in the opinion of the enrolling physician would interfere with participation in the trial

8. Current active participation in an investigational drug trial

Related Conditions & MeSH terms

• Cannabis Use Disorder
• Hyperemesis Gravidarum
• Marijuana Abuse

Intervention

Drug:
• Ondansetron 8mg
Ondansetron 8 MG prepared in a 100 mL normal saline min-bag
• Haloperidol 0.05mg/kg
Haloperidol 0.05 mg/kg prepared in a 100 mL normal saline min-bag
• Haloperidol 0.1mg/kg
Haloperidol 0.1 mg/kg prepared in a 100 mL normal saline min-bag

Locations

Country	Name	City	State
Canada	Hotel Dieu Hospital	Kingston	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	Queen's University	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Marco L.A. Sivilotti

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in pain	Changes in abdominal pain score at 1, 2, 24 and 48 hours vs. baseline	1, 2, 24 and 48 hours
Secondary	Change in nausea	Changes in nausea score at 1, 2, 24 and 48 hours vs. baseline	1, 2, 24 and 48 hours
Secondary	Treatment success	Treatment success = both abdominal pain and nausea score < 2 at 2, 24 and 48 hours	2, 24 and 48 hours
Secondary	Oral intake	Cumulative oral intake from t=0 to 2 hours (in mL)	2 hours
Secondary	Emesis volume	Cumulative emesis from t=0 to 2 hours (in mL)	2 hours
Secondary	Urine output	Cumulative urine output (in mL)	2 hours
Secondary	Discharge ready at 2 hours	Deemed discharge-ready at 2 hours in the opinion of the treating physician	2 hours
Secondary	Rescue anti-emetics in ED	Given rescue anti-emetics prior to discharge	at discharge from Emergency Department or 12 hours whichever comes first
Secondary	Time to discharge from ED	Time interval to discharge-ready from t=0 (min)	at discharge from Emergency Department or 12 hours whichever comes first
Secondary	Subject preferred arm	Subject preference of high- vs low-dose haloperidol, and of haloperidol vs ondansetron (-10, 10)	2 hours
Secondary	Return to ED	Unscheduled return visits to ED within 7 days (count)	7 days
Secondary	ED consult	Consulted to admitting service	From time of study intervention until admitting service consulted or subject discharged from Emergency Department, whichever comes first, assessed up to 48 hours
Secondary	Prolonged ED Length of stay	Outcome 10 "Time to Discharge from ED" > 12 hours (binary yes/no)	at discharge from Emergency Department or 12 hours whichever comes first