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Trial record 39 of 139 for:    cannabis | Recruiting, Enrolling by invitation Studies

Haloperidol Versus Ondansetron for Cannabis Hyperemesis Syndrome (HaVOC) (HaVOC)

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ClinicalTrials.gov Identifier: NCT03056482
Recruitment Status : Recruiting
First Posted : February 17, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Marco L.A. Sivilotti, Queen's University

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

Condition or disease Intervention/treatment Phase
Cannabis Use Disorder Drug: Ondansetron 8mg Drug: Haloperidol 0.05mg/kg Drug: Haloperidol 0.1mg/kg Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Haloperidol Versus Ondansetron for Cannabis Hyperemesis Syndrome (HaVOC): A Randomized Controlled Trial
Actual Study Start Date : May 21, 2017
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Ondansetron 8mg
8mg Ondansetron prepared in a 100mL normal saline mini-bag
Drug: Ondansetron 8mg
Ondansetron 8 MG prepared in a 100 mL normal saline min-bag
Other Name: Zofran
Experimental: Haloperidol 0.05mg/kg
0.05mg/kg of Haloperidol prepared in a 100mL normal saline mini-bag
Drug: Haloperidol 0.05mg/kg
Haloperidol 0.05 mg/kg prepared in a 100 mL normal saline min-bag
Other Name: Haldol
Experimental: Haloperidol 0.1mg/kg
0.1mg/kg of Haloperidol prepared in a 100mL normal saline mini-bag
Drug: Haloperidol 0.1mg/kg
Haloperidol 0.1 mg/kg prepared in a 100 mL normal saline min-bag
Other Name: Haldol



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Change in nausea [ Time Frame: 1, 2, 24 and 48 hours ]
    Changes in nausea score at 1, 2, 24 and 48 hours vs. baseline

  3. Treatment success [ Time Frame: 2, 24 and 48 hours ]
    Treatment success = both abdominal pain and nausea score < 2 at 2, 24 and 48 hours

  4. Oral intake [ Time Frame: 2 hours ]
    Cumulative oral intake from t=0 to 2 hours (in mL)

  5. Emesis volume [ Time Frame: 2 hours ]
    Cumulative emesis from t=0 to 2 hours (in mL)

  6. Urine output [ Time Frame: 2 hours ]
    Cumulative urine output (in mL)

  7. Discharge ready at 2 hours [ Time Frame: 2 hours ]
    Deemed discharge-ready at 2 hours in the opinion of the treating physician

  8. 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

  9. 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)

  10. Subject preferred arm [ Time Frame: 2 hours ]
    Subject preference of high- vs low-dose haloperidol, and of haloperidol vs ondansetron (-10, 10)

  11. Return to ED [ Time Frame: 7 days ]
    Unscheduled return visits to ED within 7 days (count)

  12. 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

  13. 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)



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056482


Contacts
Contact: Nicole L O'Callaghan, MSc 613-549-6666 ext 3793 ocallagn@kgh.kari.net
Contact: Jessica Montagner 613-548-2368 montagnj@kgh.kari.net

Locations
Canada, Ontario
Hotel Dieu Hospital Recruiting
Kingston, Ontario, Canada, K7L 2V7
Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 2V7
Queen's University Recruiting
Kingston, Ontario, Canada, K7L 3N6
Contact: Marco LA Sivilotti, MD, MSc    613-548-2368    marco.sivilotti@queensu.ca   
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Marco LA Sivilotti, MD, MSc Dept. of Emergency Medicine, Queen's University

Responsible Party: Dr. Marco L.A. Sivilotti, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT03056482     History of Changes
Other Study ID Numbers: EMED-251-17
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dr. Marco L.A. Sivilotti, Queen's University:
cannabis
haloperidol
ondansetron
hyperemesis
cyclic vomiting syndrome

Additional relevant MeSH terms:
Marijuana Abuse
Hyperemesis Gravidarum
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Morning Sickness
Pregnancy Complications
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Ondansetron
Haloperidol
Haloperidol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents
Dopamine Antagonists