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Frequent Ketamine Use and Gastrointestinal, Liver and Biliary Sequelae

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ClinicalTrials.gov Identifier: NCT02165488
Recruitment Status : Completed
First Posted : June 17, 2014
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Wai-Kay Seto, The University of Hong Kong

Study Description
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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.

Condition or disease
Gastritis Peptic Ulcer Disease Cholangiopathy Liver Fibrosis

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 Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gastrointestinal, Hepatic and Biliary Sequelae of Frequent Ketamine Use: a Prospective Observational Study
Study Start Date : June 2014
Actual Primary Completion Date : May 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Incidence of cholangiopathic changes [ Time Frame: 3 months ]
  2. Incidence of peptic ulcer disease [ Time Frame: 3 months ]
  3. Incidence of liver fibrosis [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Long-term outcome of peptic ulcer disease in ketamine users [ Time Frame: 24 months ]
  2. Long-term outcome of liver fibrosis in ketamine users [ Time Frame: up to 24 months ]
  3. Long-term outcomes of cholangiopathic changes in ketamine users [ Time Frame: Up to 24 months ]

Biospecimen Retention:   Samples With DNA
Saved plasma samples Gastric antral and duodenal histology obtained by upper GI endoscopy

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02165488


Locations
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Hong Kong
The University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wai-Kay Seto, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02165488    
Other Study ID Numbers: UW14-237
First Posted: June 17, 2014    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Keywords provided by Wai-Kay Seto, The University of Hong Kong:
ketamine
abuse
abdominal discomfort
cholangiopathy
Additional relevant MeSH terms:
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Liver Cirrhosis
Peptic Ulcer
Gastritis
Fibrosis
Pathologic Processes
Liver Diseases
 Digestive System Diseases
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Stomach Diseases
Gastroenteritis