Treatment Strategies in CHS

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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. To learn more about how cannabis use relates to the management of CHS.

2. To learn if haloperidol is effective in treating the symptoms of CHS.

Eligibility:

Alberta residents with ongoing cannabis use, who have completed the baseline study, are ≥ 18 years and ≤ 65 years, and have gastrointestinal symptomology as measured by GCSI > 2 or PAGI-SYM > 2 (upper or lower abdominal pain subscale).

Design:

Participants will answer a series of questionnaires online. Study specific questions relating to symptoms, cannabis use, and anxiety and depression will be administered. Confirmation of cannabis cessation will be assessed with urine creatinine and cannabis metabolite measures. Salivary cortisol will be used to asses the stress response.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Calgary
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Haloperidol; Haloperidol decanoate

Criteria

Inclusion Criteria:

1. Completed Baseline study prior to enrollment

2. Age ≥ 18 years and ≤ 65 years

3. Gastrointestinal symptomology as measured by GCSI > 2 or PAGI-SYM > 2 (upper or lower abdominal pain subscale)

4. Ongoing cannabis use (> 1g/wk)

5. Resident of Alberta with valid Alberta Health Care number

Exclusion Criteria:

1. Pregnancy and/or breastfeeding

2. Corrected QT interval measured on ECG > 450 ms for males or >470 ms for females

3. History of seizure, venous thromboembolism (VTE), psychosis, Parkinson's disease or spastic disorder

4. Concurrent diagnosis of or suspected gastroparesis or functional dyspepsia

5. Diabetes with neuropathy.

6. Any gastrointestinal, neurological, or other illness felt by the investigators to be potentially involved in symptom generation or pose a safety risk to inclusion in this study.

7. Previous gastric or intestinal surgery which may lead to symptoms

8. 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).