Haloperidol Versus Ondansetron for Cannabis Hyperemesis Syndrome (HaVOC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-21

Study Completion Date

2019-07-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing Haloperidol to Olanzapine in the Treatment of Suspected Cannabinoid Hyperemesis in the Emergency Department

NCT07246187

Cannabinoid Hyperemesis Syndrome

RECRUITING PHASE3

Treatment Strategies in CHS

NCT04176055

Cannabis Hyperemesis Syndrome

COMPLETED PHASE4

Observational Study of THC Concentrations in Acute Cannabis-induced CNS Depression

NCT06017622

Acute Cannabinoid Intoxication

ACTIVE_NOT_RECRUITING

Cannabinoid Hyperemesis Syndrome. Prospective Multicenter Study of Patients Admitted to Adult Emergency Departments in Maine-et-Loire.

NCT06660901

D000096704 Cannabinoid Hyperemesis Syndrome

RECRUITING

Haloperidol Prophylaxis in Older Emergency Department Patients

NCT01530308

Delirium

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cannabis Use Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ondansetron 8mg

8mg Ondansetron prepared in a 100mL normal saline mini-bag

Group Type ACTIVE_COMPARATOR

Ondansetron 8mg

Intervention Type DRUG

Ondansetron 8 MG prepared in a 100 mL normal saline min-bag

Haloperidol 0.05mg/kg

0.05mg/kg of Haloperidol prepared in a 100mL normal saline mini-bag

Group Type EXPERIMENTAL

Haloperidol 0.05mg/kg

Intervention Type DRUG

Haloperidol 0.05 mg/kg prepared in a 100 mL normal saline min-bag

Haloperidol 0.1mg/kg

0.1mg/kg of Haloperidol prepared in a 100mL normal saline mini-bag

Group Type EXPERIMENTAL

Haloperidol 0.1mg/kg

Intervention Type DRUG

Haloperidol 0.1 mg/kg prepared in a 100 mL normal saline min-bag

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ondansetron 8mg

Ondansetron 8 MG prepared in a 100 mL normal saline min-bag

Intervention Type DRUG

Haloperidol 0.05mg/kg

Haloperidol 0.05 mg/kg prepared in a 100 mL normal saline min-bag

Intervention Type DRUG

Haloperidol 0.1mg/kg

Haloperidol 0.1 mg/kg prepared in a 100 mL normal saline min-bag

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Zofran Haldol Haldol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No