GastritisNCT02165488
Frequent Ketamine Use and Gastrointestinal, Liver and Biliary Sequelae
An observational study of Gastritis and Peptic Ulcer Disease, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gastritis, Peptic Ulcer Disease, Cholangiopathy
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- Jun 2014to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastritis, Peptic Ulcer Disease, Cholangiopathy, Liver Fibrosis
- Keywords
- ketamine, abuse, abdominal discomfort, cholangiopathy
- Medical subject headings
- Gastritis, Peptic Ulcer, Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cholangiopathic changes
Measured: 3 months
Incidence of peptic ulcer disease
Measured: 3 months
Incidence of liver fibrosis
Measured: 3 months
Secondary outcomes (3)
Long-term outcome of peptic ulcer disease in ketamine users
Measured: 24 months
Long-term outcome of liver fibrosis in ketamine users
Measured: up to 24 months
Long-term outcomes of cholangiopathic changes in ketamine users
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastritisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wai-Kay Seto, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165488
- Sponsor's protocol ID
- UW14-237
- Status last verified
- Mar 2020
- First submitted
- 8 Jun 2014
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29551711
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal, Hepatic and Biliary Sequelae of Frequent Ketamine Use: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02165488
- Acronym / sponsor ID
- UW14-237
- Conditions
- Gastritis, Peptic Ulcer Disease, Cholangiopathy, Liver Fibrosis
- Keywords
- ketamine, abuse, abdominal discomfort, cholangiopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- May 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 17 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Derived from this study: PubMed 29551711Seto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastritis and Peptic Ulcer Disease, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cholangiopathic changes (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02165488, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.