Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04176055 |
Other study ID # |
REB19-1197 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
October 13, 2020 |
Est. completion date |
June 1, 2022 |
Study information
Verified date |
August 2022 |
Source |
University of Calgary |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
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.The pathophysiology of CHS is poorly
understood but may involve alterations gut motility and/or activation of the
hypothalamic-pituitary-adrenal (HPA) axis.
Our endogenous endocannabinoid system contains the cannabinoid receptor type I (CB1) and type
II (CB2), and their ligands, anandamide (AEA) and 2-arachidonylglycerol (2-AG). CB1 receptors
are widely distributed throughout the central and peripheral nervous system, including the
myenteric plexus of the GI tract. In humans, oral Δ9-THC (an active cannabis compound)
reduces gastric emptying and patients with slow transit constipation have increased
expression of endogenous endocannabinoids and higher CB1 receptor expression. In CHS, chronic
cannabis use may cause significant activation of peripheral, gut-located CB1.
The hypothalamic-pituitary- adrenal (HPA) axis, the main neuroendocrine system activated in
response to stressful stimuli may also be involved in CHS. Activation of centrally located
CB1 receptors by 2-AG plays a crucial role in down-regulating the HPA axis in recovery from
stress. Reduction in 2-AG activity within the hypothalamus by stress, leads to reduced
hypothalamic CB1 receptor activation; this reduced CB1 activation is also observed in
prolonged cannabis use.
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 and has become a first-line agent for acute CHS.
Outcome measures:
The primary endpoints will look at the correlation between quantitative weekly cannabis use
and gastrointestinal symptoms at week 8 and the mean change of the GI symptoms from week 8 to
week 12 during.