Frequent Ketamine Use and Gastrointestinal, Liver and Biliary Sequelae

NCT ID: NCT02165488

Last Updated: 2020-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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The recreational use of psychotropic drugs has been increasing over the past 2 decades in Hong Kong. Ketamine hydrochloride is currently one of the most popular recreational drugs in Hong Kong, and its recreational use is also increasing in the United Kingdom and Europe. Inhalation of ketamine could result in hallucinations, out-of-the-body experiences and psychological dissociation, making it popular among young adults. One of the well-known side effects of ketamine is bladder dysfunction, which is seen in one-quarter of chronic ketamine users .

Ketamine has also been known to be associated with gastrointestinal symptoms. Colicky epigastric / abdominal discomfort in ketamine users, known as "K-cramps", has been reported in 33.3% of frequent ketamine users, and is the second-most common symptom of presentation (21%) among ketamine users in the emergency department . Nonetheless, the underlying etiology resulting in this abdominal discomfort remains poorly defined. A possible etiology is intestinal motility disorders, since ketamine interferes with gastric motility. Another possible cause could be ketamine-related cholangiopathy, which has been described in both Asia and Western countries. Another possible cause could be ketamine-related liver dysfunction, which is seen in 16% of ketamine users. Chronic ketamine hepatotoxicity is associated with mitochondrial liver injury , and could result in bridging liver fibrosis.

We plan to recruit subjects from ketamine users seeking medical attention at substance abuse clinics in different psychiatric clusters in Hong Kong. A screening log will be kept on the total number of ketamine users attending different substance abuse clinics and the number of potential subjects referred to our center.

Baseline sociodemographic information will be obtained. A standardized method will be used to assess and quantify the degree of ketamine use, as well as the recreational use of other psychotropic drugs (e.g. ecstasy, methamphetamine, marijuana etc.) and alcohol intake. Subjects will then be assessed for the presence or absence of dyspepsia, biliary-type abdominal pain, gastroparesis or other abdominal symptoms following standard criteria.

Conditions

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Gastritis Peptic Ulcer Disease Cholangiopathy Liver Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Wai-Kay Seto

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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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.

Reference Type DERIVED
PMID: 29551711 (View on PubMed)

Other Identifiers

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UW14-237

Identifier Type: -

Identifier Source: org_study_id

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