CompletedPhase 4

Treatment Strategies in CHS

Canada4 participantsStarted 2020-10-13

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. Pregnancy and/or breastfeeding
. Corrected QT interval measured on ECG \> 450 ms for males or \>470 ms for females

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Mean change in GI symptoms from week 8 to week 12

Timeframe: final 4 weeks of the 12 week study for outcome 2

Trial details

NCT IDNCT04176055

SponsorUniversity of Calgary

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-01

View on ClinicalTrials.gov More Cannabis Hyperemesis Syndrome trials