Addiction, SubstanceEPILOGUENCT04343339
Evolution of Psychoactive Substances Consumption in Connection With COVID-19 Containment
An observational study of Addiction, Substance and COVID-19, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The current containment linked to COVID-19 will have consequences for people suffering from addiction and there is a risk of overdoses when the containment ends. So the investigators hypothesize that this health crisis is an opportunity to develop risk reduction and access to care for vulnerable people who lives with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Addiction, Substance, COVID-19
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2020to 30 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Person who lives with an addiction accepting the principle of the study
Who may be able to join
- >18 years
- Accept study
- live with an addiction
Who cannot join
- not being able to answer the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolution of Psychoactive Substances Consumption in Connection With COVID-19 Containment - EPILOGUE
The current containment linked to COVID-19 will have consequences for people suffering from addiction and there is a risk of overdoses when the containment ends. So the investigators hypothesize that this health crisis is an opportunity to develop risk reduction and access to care for vulnerable people who lives with an addiction.
The main objective of this study is to describe the changes in the psychoactive substances consumption during the containment in people suffering from addiction. The secondary objectives are to describe the evolution at 1 month from the end of the containment of problematic consumption and the level of access to care of these users
- Conditions
- Addiction, Substance, COVID-19
- Keywords
- Risk of overdose on de-confinment, COVID-19 containment will change drugs practices, COVID-19 containment will changes access to care, Addiction is a common disease, Alcohol, Containment, Drug use
- Medical subject headings
- Substance-Related Disorders, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of consumption
measurement of the difference in drugs consumption caused by containment (delta)
Measured: 1 day
Evolution of consumption
measurement of the difference in drugs consumption caused by containment (delta)
Measured: 1 month after confinmant
Secondary outcomes (2)
health care access
number of drug users referred to care (%)
Measured: 1 day
health care access
number of drug users referred to care (%)
Measured: 1 month after confinmant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start8 Apr 2020
- Primary completion30 Jul 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Addiction, SubstanceStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène Donnadieu-Rigole, MD PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343339
- Sponsor's protocol ID
- RECHMPL20_0195
- Acronym
- EPILOGUE
- Status last verified
- Apr 2020
- First submitted
- 8 Apr 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Psychoactive Substances Consumption in Connection With COVID-19 Containment - EPILOGUE
- ClinicalTrials.gov ID
- NCT04343339
- Acronym / sponsor ID
- EPILOGUE / RECHMPL20_0195
- Conditions
- Addiction, Substance, COVID-19
- Keywords
- Risk of overdose on de-confinment, COVID-19 containment will change drugs practices, COVID-19 containment will changes access to care, Addiction is a common disease, Alcohol, Containment, Drug use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 13 Apr 2020 (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.
The current containment linked to COVID-19 will have consequences for people suffering from addiction and there is a risk of overdoses when the containment ends. So the investigators hypothesize that this health crisis is an opportunity to develop risk reduction and access to care for vulnerable people who lives with an addiction.
The main objective of this study is to describe the changes in the psychoactive substances consumption during the containment in people suffering from addiction. The secondary objectives are to describe the evolution at 1 month from the end of the containment of problematic consumption and the level of access to care of these users
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Person who lives with an addiction accepting the principle of the study
Key inclusion criteria (3 listed)
- >18 years
- Accept study
- live with an addiction
Key exclusion criteria (1 listed)
- not being able to answer the questionnaire
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
Evolution of consumption
Time frame: 1 day
measurement of the difference in drugs consumption caused by containment (delta)
Evolution of consumption
Time frame: 1 month after confinmant
measurement of the difference in drugs consumption caused by containment (delta)
2 secondary outcomes
health care access
Time frame: 1 day
health care access
Time frame: 1 month after confinmant
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 8 Oct 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Hélène Donnadieu-Rigole, MD PhD study director
University Hospital, Montpellier
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 Addiction, Substance and COVID-19, run by University Hospital, Montpellier at 1 site in France.
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 3 inclusion and 1 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 8 Oct 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 France. 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?
Evolution of consumption (time frame: 1 day). The study lists 2 primary outcomes in all. 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 8 Oct 2020.