Haloperidol vs Olanzapine for CHS

(CH2O Trial)

Overseen By Joseph Jabour, DO FACEP

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Mercy Bon Secours Saint Vincent Medical Center

Must not be taking: Benzodiazepines, Antipsychotics

Disqualifiers: Under 18, Pregnancy, Parkinson's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

114 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether haloperidol or olanzapine more effectively treats nausea and abdominal pain associated with cannabinoid hyperemesis syndrome (CHS), a condition causing repeated vomiting in regular cannabis users. The study will assess the effectiveness of each medication in alleviating these symptoms. It suits individuals who use cannabis nearly daily and have been diagnosed with CHS or experience recurrent vomiting episodes. Participants will be divided into two groups to test each medication. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot participate if you are taking drugs that should not be used with haloperidol or olanzapine, or if you are already taking antipsychotics.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Past research on haloperidol revealed some safety concerns. One study found that 13% of patients experienced restlessness, known as akathisia, and 38% returned to the doctor due to ongoing nausea or other side effects. This indicates that while haloperidol can be effective, it may cause uncomfortable side effects for some individuals.

Olanzapine presents different findings. Although not officially approved for Cannabinoid Hyperemesis Syndrome (CHS), it is often used for this condition and tends to cause fewer movement-related side effects compared to other drugs. This suggests it might be gentler on the body for some patients.

Both drugs have been available for a while and are generally well-tolerated, but some individuals might experience side effects. Discussing any concerns with a doctor before joining a clinical trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for Cannabinoid Hyperemesis Syndrome (CHS) because they offer new possibilities beyond traditional antiemetic therapies. Haloperidol, typically used as an antipsychotic, is being explored for its potential to alleviate nausea through dopamine receptor blockade, which could offer relief where standard antiemetics might not suffice. Olanzapine, another antipsychotic, also shows promise due to its ability to target multiple neurotransmitter pathways, potentially providing a broader spectrum of symptom relief. These treatments are intriguing because they could address CHS symptoms more effectively by acting on different pathways compared to existing options.

What evidence suggests that this trial's treatments could be effective for CHS?

This trial will compare Haloperidol and Olanzapine for treating symptoms of cannabinoid hyperemesis syndrome (CHS). Research has shown that both drugs can help treat CHS symptoms. Participants in the Haloperidol arm may experience quick relief from symptoms like nausea and stomach pain, often allowing them to leave the hospital within hours. Reports indicate that haloperidol reduces the need for additional medications and shortens hospital stays. Meanwhile, participants in the Olanzapine arm may find it effective in managing CHS symptoms, with patients responding well to treatment. Olanzapine also tends to cause fewer movement-related side effects compared to some other treatments. This trial aims to determine which drug is more effective for CHS, but evidence supports the potential benefits of both. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals who are experiencing nausea and abdominal pain due to Cannabinoid Hyperemesis Syndrome (CHS) and are currently in the emergency department. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

My doctor thinks my vomiting might be caused by cannabis use.

I use cannabis almost every day by smoking or vaping for 6 months or more.

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

Exclusion Criteria

I am under 18 years old.

I weigh less than 50 kg.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive either Haloperidol or Olanzapine intramuscularly and are monitored for nausea and abdominal pain using a visual analog scale

1 day

1 visit (in-person)

Follow-up

Participants are monitored for discharge readiness and any need for rescue antiemetics or further treatment

60-120 minutes

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Haloperidol
• Olanzapine

Trial Overview The study aims to compare the effectiveness of Haloperidol versus Olanzapine, each at a dose of 10 milligrams, in treating symptoms of CHS. Effectiveness will be measured using a visual scale for assessing nausea and pain.

How Is the Trial Designed?

Group I: Haloperidol arm Active Control 1 Intervention

haloperidol

Group II: Olanzapine arm Active Control 1 Intervention

olanzapine

Who Is Running the Clinical Trial?

Mercy Bon Secours Saint Vincent Medical Center

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5256592/

Is haloperidol the wonder drug for cannabinoid ... The present report highlights the use of haloperidol as an agent that successfully and safely treats the unrelenting symptoms of CHS.

2. journals.lww.com journals.lww.com/americantherapeutics/fulltext/2017/01000/haloperidol,_a_novel_treatment_for_cannabinoid.10.aspx

Haloperidol, a Novel Treatment for Cannabinoid ... Haloperidol was successful in treating our 4 patients with CHS. All of our cases obtained significant symptomatic relief and were discharged within 8 hours of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04176055?term=AREA%5BInterventionSearch%5D(HALOPERIDOL)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=4

Study Details | NCT04176055 | Treatment Strategies in CHS Currently, the generally accepted management for CHS is complete cannabis abstinence as traditional anti-emetics appear to be minimally effective. Preliminary ...

4. annemergmed.com annemergmed.com/article/S0196-0644(22)00639-4/fulltext

32 Droperidol on Prevention of Emesis from Cannabinoid ... Previous studies have reported fewer rescue medications required, shorter time to discharge, and fewer return visits to the ED with the use of haloperidol for ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0196064420306661

Intravenous Haloperidol Versus Ondansetron for Cannabis ... This study suggests that haloperidol is superior to ondansetron for cannabis-induced hyperemesis. Anecdotal evidence has emerged in favor of haloperidol, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11721739/

Mitigating the Risk of QTc Prolongation When Using ... Patients with CHS are at higher risk of QTc prolongation due to cannabis use, electrolyte imbalance, and antiemetic medications.

7. hopkinsmedicine.org hopkinsmedicine.org/-/media/files/allchildrens/clinical-pathways/chs_pathway-2025-08-18.pdf

Cannabinoid Hyperemesis Syndrome Clinical Pathway The Haloperidol versus Ondansetron for Cannabis Hyperemesis Syndrome (HaVOC) study is a randomized controlled trial that demonstrated promising ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0196064422006394

32 Droperidol on Prevention of Emesis from Cannabinoid ... Recent prospective studies have demonstrated the superiority of haloperidol, a dopamine antagonist, over ondansetron for the treatment of CHS. Interim analysis ...

9. link.springer.com link.springer.com/article/10.1007/s43678-021-00122-x

Haloperidol as an anti-emetic for Cannabis Hyperemesis ... Safety outcomes in Haloperidol (0.1 mg/kg) group found 1-episode akathisia (13%), and 3 (38%) return visits (1 ongoing nausea, 2 dystonic ...

10. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/1742-6723.13944

Cannabinoid hyperemesis syndrome: A 6‐year audit of ... Cannabinoid hyperemesis syndrome (CHS) is a condition characterised by cyclical nausea, vomiting and in some cases, abdominal pain in the setting of regular ...