Clinical Trial: Haloperidol Versus Ondansetron for Cannabis Hyperemesis Syndrome (HaVOC)

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Queen's University

Current Primary Outcome: Change in pain and nausea [ Time Frame: 2 hours ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in pain [ Time Frame: 1, 2, 24 and 48 hours ]
    Changes in abdominal pain score at 1, 2, 24 and 48 hours vs. baseline
  • Change in nausea [ Time Frame: 1, 2, 24 and 48 hours ]
    Changes in nausea score at 1, 2, 24 and 48 hours vs. baseline
  • Treatment success [ Time Frame: 2, 24 and 48 hours ]
    Treatment success = both abdominal pain and nausea score < 2 at 2, 24 and 48 hours
  • Oral intake [ Time Frame: 2 hours ]
    Cumulative oral intake from t=0 to 2 hours (in mL)
  • Emesis volume [ Time Frame: 2 hours ]
    Cumulative emesis from t=0 to 2 hours (in mL)
  • Urine output [ Time Frame: 2 hours ]
    Cumulative urine output (in mL)
  • Discharge ready at 2 hours [ Time Frame: 2 hours ]
    Deemed discharge-ready at 2 hours in the opinion of the treating physician
  • Rescue anti-emetics in ED [ Time Frame: at discharge from Emergency Department or 12 hours whichever comes first ]
    Given rescue anti-emetics prior to discharge
  • Time to discharge from ED [ Time Frame: at discharge from Emergency Department or 12 hours whichever comes first ]
    Time interval to discharge-ready from t=0 (min)
  • Subject preferred arm [ Time Frame: 2 hours ]
    Subject preference of high- vs low-dose haloperidol, and of haloperidol vs ondansetron (-10, 10)
  • Return to ED [ Time Frame: 7 days ]
    Unscheduled return visits to ED within 7 days (count)
  • ED consult [ Time Frame: 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 [ Time Frame: at discharge from Emergency Department or 12 hours whichever comes first ]
    Outcome 10 "Time to Discharge from ED" > 12 hours (binary yes/no)


Original Secondary Outcome: Same as current

Information By: Queen's University

Dates:
Date Received: January 23, 2017
Date Started: April 3, 2017
Date Completion: July 1, 2019
Last Updated: February 14, 2017
Last Verified: February 2017