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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

Tracking Information
First Submitted Date June 8, 2014
First Posted Date June 17, 2014
Last Update Posted Date March 25, 2020
Study Start Date June 2014
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 13, 2014)
  • Incidence of cholangiopathic changes [ Time Frame: 3 months ]
  • Incidence of peptic ulcer disease [ Time Frame: 3 months ]
  • Incidence of liver fibrosis [ Time Frame: 3 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 13, 2014)
  • Long-term outcome of peptic ulcer disease in ketamine users [ Time Frame: 24 months ]
  • Long-term outcome of liver fibrosis in ketamine users [ Time Frame: up to 24 months ]
  • Long-term outcomes of cholangiopathic changes in ketamine users [ Time Frame: Up to 24 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Frequent Ketamine Use and Gastrointestinal, Liver and Biliary Sequelae
Official Title Gastrointestinal, Hepatic and Biliary Sequelae of Frequent Ketamine Use: a Prospective Observational Study
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Saved plasma samples Gastric antral and duodenal histology obtained by upper GI endoscopy
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.
Condition
  • Gastritis
  • Peptic Ulcer Disease
  • Cholangiopathy
  • Liver Fibrosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 13, 2014)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2019
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number NCT02165488
Other Study ID Numbers UW14-237
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wai-Kay Seto, The University of Hong Kong
Study Sponsor The University of Hong Kong
Collaborators Not Provided
Investigators Not Provided
PRS Account The University of Hong Kong
Verification Date March 2020