Haloperidol Versus Ondansetron for Cannabis Hyperemesis Syndrome (HaVOC)
- Conditions
- Cannabis Use Disorder
- Interventions
- Registration Number
- NCT03056482
- Lead Sponsor
- Dr. Marco L.A. Sivilotti
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Ondansetron 8mg Ondansetron 8mg 8mg Ondansetron prepared in a 100mL normal saline mini-bag Haloperidol 0.05mg/kg Haloperidol 0.05mg/kg 0.05mg/kg of Haloperidol prepared in a 100mL normal saline mini-bag Haloperidol 0.1mg/kg Haloperidol 0.1mg/kg 0.1mg/kg of Haloperidol prepared in a 100mL normal saline mini-bag
- Primary Outcome Measures
Name Time Method Change in pain and nausea 2 hours Difference between arithmetic mean of Pain Score and Nausea Score (each on a 10-cm VAS) at 2 hours versus at baseline
- Secondary Outcome Measures
Name Time Method Oral intake 2 hours Cumulative oral intake from t=0 to 2 hours (in mL)
ED consult From time of study intervention until admitting service consulted or subject discharged from Emergency Department, whichever comes first, assessed up to 48 hours Consulted to admitting service
Prolonged ED Length of stay at discharge from Emergency Department or 12 hours whichever comes first Outcome 10 "Time to Discharge from ED" \> 12 hours (binary yes/no)
Change in pain 1, 2, 24 and 48 hours Changes in abdominal pain score at 1, 2, 24 and 48 hours vs. baseline
Change in nausea 1, 2, 24 and 48 hours Changes in nausea score at 1, 2, 24 and 48 hours vs. baseline
Treatment success 2, 24 and 48 hours Treatment success = both abdominal pain and nausea score \< 2 at 2, 24 and 48 hours
Urine output 2 hours Cumulative urine output (in mL)
Discharge ready at 2 hours 2 hours Deemed discharge-ready at 2 hours in the opinion of the treating physician
Rescue anti-emetics in ED at discharge from Emergency Department or 12 hours whichever comes first Given rescue anti-emetics prior to discharge
Time to discharge from ED at discharge from Emergency Department or 12 hours whichever comes first Time interval to discharge-ready from t=0 (min)
Subject preferred arm 2 hours Subject preference of high- vs low-dose haloperidol, and of haloperidol vs ondansetron (-10, 10)
Return to ED 7 days Unscheduled return visits to ED within 7 days (count)
Emesis volume 2 hours Cumulative emesis from t=0 to 2 hours (in mL)
Trial Locations
- Locations (3)
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
Hotel Dieu Hospital
🇨🇦Kingston, Ontario, Canada
Queen's University
🇨🇦Kingston, Ontario, Canada