Haloperidol versus olanzapine for treating cannabinoid hyperemesis in the emergency department

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

This study will test whether a single intramuscular dose of haloperidol or olanzapine works better to quickly reduce nausea and abdominal pain in adults with suspected cannabinoid hyperemesis who use cannabis near-daily.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 114 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Mercy Bon Secours Saint Vincent Medical Center (Academic / other)
• Locations: 1 site (Toledo, Ohio)
• Trial ID: NCT07246187 on ClinicalTrials.gov

What this trial studies

Adults who are near-daily cannabis users with suspected cannabinoid hyperemesis will be randomly assigned to receive a single intramuscular dose of haloperidol 5 mg or olanzapine 10 mg in a blinded fashion in the emergency department. Baseline nausea and abdominal pain will be recorded on 10-point visual analog scales and repeated at 60 minutes and again between 60–120 minutes after treatment while patients receive standard supportive care and monitoring. Standard labs, ECG, and cardiac/oxygen monitoring will be performed per ED routine, and opaque syringes will be used to maintain blinding. The main outcome is the change in VAS scores for nausea and abdominal pain between the two drugs.

Who should consider this trial

Good fit: Adults (≥18 years) who inhale cannabis near-daily for at least six months and have suspected or recurrent cannabinoid hyperemesis (prior diagnosis or ≥3 cyclic vomiting episodes) are the intended participants.

Not a fit: People under 18, weighing less than 50 kg, pregnant or breastfeeding women, those on daily benzodiazepines or contraindicated medications, with prolonged QTc, Parkinson's disease, or current antipsychotic use are excluded and would not benefit from enrolling.

Why it matters

Potential benefit: If successful, the results could identify the faster-acting and more effective medication for relieving nausea and abdominal pain in cannabinoid hyperemesis, improving emergency department care and patient comfort.

How similar studies have performed: Smaller emergency-department case series and retrospective studies suggest haloperidol and olanzapine can relieve symptoms in cannabinoid hyperemesis, but head-to-head randomized data are limited.

Eligibility criteria

Inclusion Criteria:

* subjects must meet ONE of the below criteria AND are a near-daily to daily user of cannabis by inhalation for greater than or equal to 6 months.

  1. Have documented previous diagnosis of cannabinoid hyperemesis, or
  2. Report (or on chart review) greater than or equal to 3 episodes of emesis in a cyclic pattern separated by greater than 1 month during the preceding 2 years, or
  3. The provider suspects cannabinoid hyperemesis as the primary or equally likely primary diagnosis.

Exclusion Criteria:

* Ineligible subjects include age less than 18 years, weight less than 50 kg, pregnancy, daily benzodiazepines use, prolonged QTc interval on the electrocardiogram (ECG), breastfeeding mothers, previously known allergy to or intolerance of either study drug, subjects taking drugs that are contraindicated with haloperidol or olanzapine, subjects with Parkison's Disease, subjects already taking haloperidol, olanzapine, or other antipsychotics

Where this trial is running

Toledo, Ohio

• Mercy Saint Vincent Medical Center — Toledo, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: Joseph Jabour, DO FACEP

Conditions Cannabinoid Hyperemesis Syndrome