NCT03056482

Haloperidol Versus Ondansetron for Cannabis Hyperemesis Syndrome (HaVOC)

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Dr. Marco L.A. Sivilotti · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Cannabis Use Disorder

Interventions

Type	Name	Description
DRUG	Ondansetron 8mg	Ondansetron 8 MG prepared in a 100 mL normal saline min-bag
DRUG	Haloperidol 0.05mg/kg	Haloperidol 0.05 mg/kg prepared in a 100 mL normal saline min-bag
DRUG	Haloperidol 0.1mg/kg	Haloperidol 0.1 mg/kg prepared in a 100 mL normal saline min-bag

Timeline

• Start date: 2017-05-21
• Primary completion: 2019-06-30
• Completion: 2019-07-07
• First posted: 2017-02-17
• Last updated: 2024-04-03

Locations

3 sites across 1 country: Canada