Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome

NCT04283292 | Completed Phase 4

• 1 other identifier: 21957
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine if capsaicin cream offers symptomatic relief to patients suffering from Cannabinoid Hyperemesis Syndrome (condition that leads to repeated and severe bouts of vomiting).

Conditions

Cannabinoid Hyperemesis Syndrome

Outcome Measures

Primary Outcomes (1)

• Time to resolution of symptoms

  Time that it takes for symptoms to be resolved for those with Cannabinoid Hyperemesis Syndrome

  1 day (During emergency department admission)

Secondary Outcomes (1)

• Clinical improvement in pain score

  1 day (During emergency department admission)

Other Outcomes (1)

• Symptom improvement at thirty days

  30 days (outpatient phone call)

Study Arms (2)

Capsaicin

EXPERIMENTAL

capsaicin 0.075% cream applied once topically

Drug: Capsaicin

Placebo

ACTIVE COMPARATOR

placebo cream applied once topically

Drug: Placebo

Interventions

Capsaicin DRUG

Topical Capsaicin for the treatment of Cannabinoid Hyperemesis Syndrome

Also known as: Zostrix

Capsaicin

Placebo DRUG

Placebo cream that is applied once topically

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old
• Diagnosis of cannabinoid hyperemesis syndrome

You may not qualify if:

• Patients who receive more than 2 anti-emetic therapies prior to screening for enrollment
• Patients who receive haloperidol as an anti-emetic therapy
• Pregnant women
• Prisoners

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

UVA Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Cannabinoid Hyperemesis Syndrome

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Marijuana Abuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Angela Holian, PharmD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: investigational pharmacists and designated personell will the only unblinded study staff.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Medicine Clinical Pharmacist

Model Details: Randomized to capsaicin or placebo in a 1:1 ratio (like the flip of a coin).

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: February 25, 2020
• Study Start: December 1, 2020
• Primary Completion: March 18, 2022
• Study Completion: March 18, 2022
• Last Updated: October 18, 2024

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)