Frequent Ketamine Use and Gastrointestinal, Liver and Biliary Sequelae
Gastrointestinal, Hepatic and Biliary Sequelae of Frequent Ketamine Use: a Prospective Observational Study
1 other identifier
observational
100
1 country
1
Brief Summary
30% of ketamine users complain of abdominal discomfort. Long-term ketamine use is associated with hepatotoxicity and pathologic changes to the biliary tract. Yet the prevalence of gastrointestinal and hepatobiliary pathologies in ketamine users has not been well-described. The investigators plan to recruit a large number of ketamine users based on referrals from different Psychiatry clusters in Hong Kong and to investigate the underlying cause of abdominal discomfort, describe the prevalence of different gastrointestinal and hepatobiliary pathologies and describe their long-term outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 8, 2014
CompletedFirst Posted
Study publicly available on registry
June 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedMarch 25, 2020
March 1, 2020
4.9 years
June 8, 2014
March 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence of cholangiopathic changes
3 months
Incidence of peptic ulcer disease
3 months
Incidence of liver fibrosis
3 months
Secondary Outcomes (3)
Long-term outcome of peptic ulcer disease in ketamine users
24 months
Long-term outcome of liver fibrosis in ketamine users
up to 24 months
Long-term outcomes of cholangiopathic changes in ketamine users
Up to 24 months
Eligibility Criteria
Recreational use of ketamine with frequency at least twice per month over 6 months within the last 2 years, with or without other illicit psychotropic drug.
You may qualify if:
- Use of ketamine or ketamine mixed with other psychotropic drugs with frequency of at least twice per month over 6 months within the last 2 years.
- Recurrent abdominal discomfort over the past 3 months or more.
- Han Chinese ethnicity.
- Age 18-60 years.
You may not qualify if:
- Mental retardation or unable to give informed consent
- Co-existing biliary disorders including recurrent pyogenic cholangitis, primary sclerosing cholangitis, IgG4 sclerosing cholangiopathy and HIV cholangiopathy.
- Other significant medical co-morbidities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Hong Kong
Hong Kong, Hong Kong
Related Publications (1)
Seto WK, Mak SK, Chiu K, Vardhanabhuti V, Wong HF, Leong HT, Lee PSF, Ho YC, Lee CK, Cheung KS, Yuen MF, Leung WK. Magnetic resonance cholangiogram patterns and clinical profiles of ketamine-related cholangiopathy in drug users. J Hepatol. 2018 Jul;69(1):121-128. doi: 10.1016/j.jhep.2018.03.006. Epub 2018 Mar 16.
PMID: 29551711DERIVED
Biospecimen
Saved plasma samples Gastric antral and duodenal histology obtained by upper GI endoscopy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
June 8, 2014
First Posted
June 17, 2014
Study Start
June 1, 2014
Primary Completion
May 1, 2019
Study Completion
December 1, 2019
Last Updated
March 25, 2020
Record last verified: 2020-03