Frequent Ketamine Use and Gastrointestinal, Liver and Biliary Sequelae

March 23, 2020 updated by: Wai-Kay Seto, The University of Hong Kong

Gastrointestinal, Hepatic and Biliary Sequelae of Frequent Ketamine Use: a Prospective Observational Study

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of cholangiopathic changes
Time Frame: 3 months
3 months
Incidence of peptic ulcer disease
Time Frame: 3 months
3 months
Incidence of liver fibrosis
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Long-term outcome of peptic ulcer disease in ketamine users
Time Frame: 24 months
24 months
Long-term outcome of liver fibrosis in ketamine users
Time Frame: up to 24 months
up to 24 months
Long-term outcomes of cholangiopathic changes in ketamine users
Time Frame: Up to 24 months
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

June 8, 2014

First Submitted That Met QC Criteria

June 13, 2014

First Posted (Estimate)

June 17, 2014

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW14-237

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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