Treatment Strategies in CHS

NCT04176055 | Completed Phase 4

• 1 other identifier: REB19-1197
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Background: In the gastrointestinal (GI) system, the most well-described manifestation of prolonged cannabis use is cannabinoid hyperemesis syndrome (CHS). CHS is characterized by severe cyclic nausea and vomiting and associated with abdominal pain.Currently, the generally accepted management for CHS is complete cannabis abstinence as traditional anti-emetics appear to be minimally effective. Preliminary reports from emergency departments suggest that intravenous haloperidol, a typical anti- psychotic, provides effective symptomatic relief in CHS. Objective:

1. 1.To learn more about how cannabis use relates to the management of CHS.
2. 2.To learn if haloperidol is effective in treating the symptoms of CHS.

Conditions

Cannabis Hyperemesis Syndrome

Outcome Measures

Primary Outcomes (2)

• Correlation between quantitative weekly cannabis use and GI symptoms at week 8

  GI symptoms will be measured PAGI-SYM, a 20-item Likert-type measure with six sub classes. Cannabis use will be measured by the cannabis consumption inventory (DFAQ-CU).The participants will fill out the questionnaires every 2 weeks.

  1st 8 weeks of the 12 week study for outcome 1

• Mean change in GI symptoms from week 8 to week 12

  GI symptoms will be measured PAGI-SYM, a 20-item Likert-type measure with six sub classes. The participants will fill out the questionnaire every 2 weeks.

  final 4 weeks of the 12 week study for outcome 2

Study Arms (1)

HALO

EXPERIMENTAL

Drug: Haloperidol

Interventions

Haloperidol DRUG

haloperidol intervention

HALO

Eligibility Criteria

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

You may qualify if:

• Completed Baseline study prior to enrollment
• Age ≥ 18 years and ≤ 65 years
• Gastrointestinal symptomology as measured by GCSI \> 2 or PAGI-SYM \> 2 (upper or lower abdominal pain subscale)
• Ongoing cannabis use (\> 1g/wk)
• Resident of Alberta with valid Alberta Health Care number

You may not qualify if:

• Pregnancy and/or breastfeeding
• Corrected QT interval measured on ECG \> 450 ms for males or \>470 ms for females
• History of seizure, venous thromboembolism (VTE), psychosis, Parkinson's disease or spastic disorder
• Concurrent diagnosis of or suspected gastroparesis or functional dyspepsia
• Diabetes with neuropathy.
• Previous gastric or intestinal surgery which may lead to symptoms
• Use of concomitant medications which cannot be stopped for the 4-week haloperidol phase of the study: including narcotics, antihistamines such as diphenhydramine (Benadryl) or dimenhydrinate (Gravol), dopamine antagonists (domperidone, metoclopramide, risperidone, clozapine, quetiapine), macrolide antibiotics, prokinetics (prucalopride), tricyclic antidepressants (TCA) at doses \>50 mg, barbiturates, 5HT3 antagonists (ondansetron).

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

MeSH Terms

Conditions

Cannabinoid Hyperemesis Syndrome

Interventions

Haloperidol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 25, 2019
• Study Start: October 13, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

CA (1)