CannabisNCT04945031
The Study of Pharmacological Treatment Pattern for Cannabis-induced Psychosis
An observational study of Cannabis, run by Mahidol University at 1 site in Thailand.
Trial summary
A cross-sectional and retrospective chart review study was conducted at the Princess Mother National Institute on Drug Abuse Treatment (PMNIDAT), Thailand. All patients who admitted at PMNIDAT from October 2013 to September 2019 were included. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cannabis
- What is being tested?
- cannabis
- How many people
- 317 participants
- Where
- 1 siteThailand
- Study dates
- 8 Nov 2019to 31 Dec 2020
- 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 12 years and older
- All sexes
- Child, Adult, Older adult
Study population: Medical chart which diagnosis by ICD-10 with cannabis-induced psychosis who admitted at PMNIDAT from October 2013 to September 2019 at Princess Mother National Institute on Drug Abuse Treatment.
Who may be able to join
- Patients ≥ 12 years of age
- Patients who had been diagnosed as Cannabis-induced psychosis by International statistical Classification of Disease and Related Health problem (ICD-10) on 2016 code F12.5
- Patients had history of use of cannabis in medical chart
- Patients had the positive urine screening test of cannabis at the first day of admission
Who cannot join
- Patients had psychosis from organic psychosis, defined by diagnosis by ICD-10 code F09.6
- Unavailable data for evaluate of outcome especially data of drug use, content of drug use or urine screening test
- Patients who cancel of medical treatment before 7 day after admission.
Trial locations and contacts
1 site in 1 country.
About this study
A cross-sectional and retrospective chart review study was conducted at the Princess Mother National Institute on Drug Abuse Treatment (PMNIDAT), Thailand. All patients who admitted at PMNIDAT from October 2013 to September 2019 were included. Patients aged 18-65 years who met the International Classification of Disease-10 (ICD-10) criteria of CIP and Had a positive urine test of cannabis were included. Cannabis use is a component cause of psychosis.More than half of symptoms of cannabis-induced psychosis (CIP) were hallucination, delusion, irritable and anxiety. Antipsychotic drug was still a key psychotropic drugs for treatment of CIP. However, antidepressants and benzodiazepines were commonly used for treatment of other symptoms beyond psychotics
- Conditions
- Cannabis
- Being tested
- cannabis
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cannabisOther
This study is observational study, we recorded history of substance used, symptoms and medication in a medical chart.
| Study group | Role | What they receive |
|---|---|---|
| cannabis-induced psychosis | Not described Receives: Other: cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacological treatment pattern for cannabis-induced psychosis
Pharmacological treatment pattern for cannabis-induced psychosis during admission
Measured: 30 days
Secondary outcomes (1)
Change of Brief psychiatric rating scale (BPRS) form the first day of admission
A high BPRS score is more severe of symptoms than a lower score
Measured: Day1, Day 8, Day 15 and Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start8 Nov 2019
- Primary completion31 May 2020
- Study completion31 Dec 2020
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 CannabisStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945031
- Sponsor's protocol ID
- MU-DT/PY-IRB2019/PY114
- Status last verified
- Jun 2021
- First submitted
- 15 Jun 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Chuenchom O, Suansanae T, Lukanapichonchut L, Suwanmajo S, Suthisisang C. Real world clinical outcomes of treatment of cannabis-induced psychosis and prevalence of cannabis-related primary psychosis: a retrospective study. BMC Psychiatry. 2024 Sep 27;24(1):626. doi: 10.1186/s12888-024-06075-6.
PubMed 39334053
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Pharmacological Treatment Pattern for Cannabis-induced Psychosis
- ClinicalTrials.gov ID
- NCT04945031
- Acronym / sponsor ID
- MU-DT/PY-IRB2019/PY114
- Conditions
- Cannabis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 8 Nov 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 30 Jun 2021 (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.
A cross-sectional and retrospective chart review study was conducted at the Princess Mother National Institute on Drug Abuse Treatment (PMNIDAT), Thailand. All patients who admitted at PMNIDAT from October 2013 to September 2019 were included. Patients aged 18-65 years who met the International Classification of Disease-10 (ICD-10) criteria of CIP and Had a positive urine test of cannabis were included. Cannabis use is a component cause of psychosis.More than half of symptoms of cannabis-induced psychosis (CIP) were hallucination, delusion, irritable and anxiety. Antipsychotic drug was still a key psychotropic drugs for treatment of CIP. However, antidepressants and benzodiazepines were commonly used for treatment of other symptoms beyond psychotics
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cannabis-induced psychosis | – | Other: cannabis |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Medical chart which diagnosis by ICD-10 with cannabis-induced psychosis who admitted at PMNIDAT from October 2013 to September 2019 at Princess Mother National Institute on Drug Abuse Treatment.
Key inclusion criteria (4 listed)
- Patients ≥ 12 years of age
- Patients who had been diagnosed as Cannabis-induced psychosis by International statistical Classification of Disease and Related Health problem (ICD-10) on 2016 code F12.5
- Patients had history of use of cannabis in medical chart
- Patients had the positive urine screening test of cannabis at the first day of admission
Key exclusion criteria (3 listed)
- Patients had psychosis from organic psychosis, defined by diagnosis by ICD-10 code F09.6
- Unavailable data for evaluate of outcome especially data of drug use, content of drug use or urine screening test
- Patients who cancel of medical treatment before 7 day after admission.
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 |
|---|---|---|
| cannabisThis study is observational study, we recorded history of substance used, symptoms and medication in a medical chart. | Other | cannabis-induced psychosis |
Primary outcome
Pharmacological treatment pattern for cannabis-induced psychosis
Time frame: 30 days
Pharmacological treatment pattern for cannabis-induced psychosis during admission
1 secondary outcome
Change of Brief psychiatric rating scale (BPRS) form the first day of admission
Time frame: Day1, Day 8, Day 15 and Day 22
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 30 Jun 2021.
- Derived from this study: PubMed 39334053Chuenchom O, Suansanae T, Lukanapichonchut L, Suwanmajo S, Suthisisang C. Real world clinical outcomes of treatment of cannabis-induced psychosis and prevalence of cannabis-related primary psychosis: a retrospective study. BMC Psychiatry. 2024 Sep 27;24(1):626. doi: 10.1186/s12888-024-06075-6.
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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 Cannabis, run by Mahidol University at 1 site in Thailand.
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 30 Jun 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 Thailand. 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?
Pharmacological treatment pattern for cannabis-induced psychosis (time frame: 30 days). 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 NCT04945031, 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 30 Jun 2021.