Methamphetamine AbuseSOPHMANCT04019600
Screening of Pulmonary Hypertension in Methamphetamine Abusers
An observational study of Methamphetamine Abuse and Pulmonary Hypertension, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Methamphetamine is misuse if classified as a "likely" risk factor for pulmonary arterial hypertension (PAH). Nevertheless the actual prevalence of and a screening strategy for PAH in methamphetamine users have not been established. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methamphetamine Abuse, Pulmonary Hypertension
- What is being tested?
- Echocardiography
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- 23 Dec 2019to 22 Dec 2022
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with a history of methamphetamine use followed-up in the participating substance abuse clinic will be identified via the computerized database of the clinical management system.
Who may be able to join
- >= 18 years at enrollment
- report of methamphetamine use in the last 2 years
- diagnosed as amphetamine dependent according to the Diagnostic and Statistical Manual of Mental Disorders (the 5th edition) (DSM-V)(13)
- voluntarily agree to participate by providing written informed consent
Who cannot join
- failed or refused to provide written informed consent
- Reference:
- 13. Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas 2013;25(2):191-2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening of Pulmonary Hypertension in Methamphetamine Abusers (SOPHMA): Rationale and Design of a Multicenter, Cross-sectional Study
Methamphetamine is misuse if classified as a "likely" risk factor for pulmonary arterial hypertension (PAH). Nevertheless the actual prevalence of and a screening strategy for PAH in methamphetamine users have not been established. In this study, the prevalence of PAH will be investigated and its independent risk factors among methamphetamine users will be identified.
Read the detailed description
Methamphetamine is a potent central nervous system stimulant originally prescribed for individuals with neuropsychiatric diseases. Owing to its highly addictive nature, illicit use has emerged as a major public health problem worldwide. It causes methamphetamine use disorders and also affects cardiovascular (CV) system.
PAH is one of those CV complications and is devastating and often life-threatening. In a subsequent retrospective cohort, patients with idiopathic PAH were found to have a much higher prevalence of prior use of methamphetamine and/or its related compounds, compared with patients with chronic thromboembolic pulmonary hypertension or pulmonary hypertension due to a known associated condition. Although current international guidelines recognize methamphetamines as a "likely" cause of drug-induced PAH, almost nothing is known about its prevalence and incidence amongst methamphetamine users.
Besides, since patients with PAH often remain asymptomatic in the early phase, the diagnosis is often made late in the course of the disease, when most small pulmonary arteries have been obliterated, rendering therapy ineffective. Although the prognosis of patients with methamphetamine-associated PAH appears to be much worse than for those with idiopathic PAH, international guidelines and expert consensus have not considered screening for PAH in asymptomatic methamphetamine users.
This study will apply a current guideline-recommended PAH screening algorithm for systemic sclerosis to a large cohort of unselected methamphetamine users in Hong Kong. The study objectives include: 1) to describe the prevalence of PAH among methamphetamine users using a current guidelines-recommended screening algorithm for PAH in systemic sclerosis; 2) to identify independent risk factors for PAH in methamphetamine users; and 3) to develop a prediction model for PAH in methamphetamine users.
- Conditions
- Methamphetamine Abuse, Pulmonary Hypertension
- Being tested
- Echocardiography
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyOther
Also called 12-lead electrocardiogram, Serum sampling for brain natriuretic peptide and other biomarkers, 6-minute walking test
Demographic data and health risk factors will be collected on day of screening, together with the above tests. Right heart catheterization will be separately arranged in patients with a high echocardiographic probability of PAH. For those with a low-intermediate echocardiographic probability, screening will be repeated within 1 year to ensure true negativity of the original scan.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of PAH in methamphetamine users
Diagnosis and subtypes, as well as prevalence of PAH in methamphetamine users
Measured: 3 years
Secondary outcomes (1)
Risk factors of PAH in methamphetamine users
Risk factors and a prediction model for PAH in methamphetamine users
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start23 Dec 2019
- Primary completion22 Dec 2022 (estimated)
- Study completion22 Dec 2022 (estimated)
Why it stopped: Recruitment in out-patient clinic has been suspended due to COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine AbuseStudies 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
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chung-Wah David SIU, The University of Hong Kong
- Investigators
- Siu-Han JoJo Hai, MBBS, Principal investigator, Cardiac Division, the University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019600
- Sponsor's protocol ID
- SOPHMA study protocol_v.1
- Acronym
- SOPHMA
- Status last verified
- Aug 2021
- First submitted
- 11 Jul 2019
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Pulmonary Hypertension in Methamphetamine Abusers (SOPHMA): Rationale and Design of a Multicenter, Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04019600
- Acronym / sponsor ID
- SOPHMA / SOPHMA study protocol_v.1
- Conditions
- Methamphetamine Abuse, Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Recruitment in out-patient clinic has been suspended due to COVID-19 pandemic
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 22 Dec 2022 (estimated)
- Study completion
- 22 Dec 2022 (estimated)
- First posted
- 15 Jul 2019 (actual)
- 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.
Methamphetamine is misuse if classified as a "likely" risk factor for pulmonary arterial hypertension (PAH). Nevertheless the actual prevalence of and a screening strategy for PAH in methamphetamine users have not been established. In this study, the prevalence of PAH will be investigated and its independent risk factors among methamphetamine users will be identified.
Detailed description
Methamphetamine is a potent central nervous system stimulant originally prescribed for individuals with neuropsychiatric diseases. Owing to its highly addictive nature, illicit use has emerged as a major public health problem worldwide. It causes methamphetamine use disorders and also affects cardiovascular (CV) system.
PAH is one of those CV complications and is devastating and often life-threatening. In a subsequent retrospective cohort, patients with idiopathic PAH were found to have a much higher prevalence of prior use of methamphetamine and/or its related compounds, compared with patients with chronic thromboembolic pulmonary hypertension or pulmonary hypertension due to a known associated condition. Although current international guidelines recognize methamphetamines as a "likely" cause of drug-induced PAH, almost nothing is known about its prevalence and incidence amongst methamphetamine users.
Besides, since patients with PAH often remain asymptomatic in the early phase, the diagnosis is often made late in the course of the disease, when most small pulmonary arteries have been obliterated, rendering therapy ineffective. Although the prognosis of patients with methamphetamine-associated PAH appears to be much worse than for those with idiopathic PAH, international guidelines and expert consensus have not considered screening for PAH in asymptomatic methamphetamine users.
This study will apply a current guideline-recommended PAH screening algorithm for systemic sclerosis to a large cohort of unselected methamphetamine users in Hong Kong. The study objectives include: 1) to describe the prevalence of PAH among methamphetamine users using a current guidelines-recommended screening algorithm for PAH in systemic sclerosis; 2) to identify independent risk factors for PAH in methamphetamine users; and 3) to develop a prediction model for PAH in methamphetamine users.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with a history of methamphetamine use followed-up in the participating substance abuse clinic will be identified via the computerized database of the clinical management system.
Key inclusion criteria (4 listed)
- >= 18 years at enrollment
- report of methamphetamine use in the last 2 years
- diagnosed as amphetamine dependent according to the Diagnostic and Statistical Manual of Mental Disorders (the 5th edition) (DSM-V)(13)
- voluntarily agree to participate by providing written informed consent
Key exclusion criteria (3 listed)
- failed or refused to provide written informed consent
- 13. Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas 2013;25(2):191-2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyAlso: 12-lead electrocardiogram, Serum sampling for brain natriuretic peptide and other biomarkers, 6-minute walking testDemographic data and health risk factors will be collected on day of screening, together with the above tests. Right heart catheterization will be separately arranged in patients with a high echocardiographic probability of PAH. For those with a low-intermediate echocardiographic probability, screening will be repeated within 1 year to ensure true negativity of the original scan. | Other | – |
Primary outcome
Diagnosis of PAH in methamphetamine users
Time frame: 3 years
Diagnosis and subtypes, as well as prevalence of PAH in methamphetamine users
1 secondary outcome
Risk factors of PAH in methamphetamine users
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Siu-Han JoJo Hai, MBBS principal investigator
Cardiac Division, the University of Hong Kong
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 Methamphetamine Abuse and Pulmonary Hypertension, 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: paused, as of the sponsor's last update on 10 Aug 2021. 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?
Results are not available in the source record.
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?
Diagnosis of PAH in methamphetamine users (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2021.