Psychiatric DisorderPhase 4HECBA-PSYNCT05583240
Influence of Olfaction Essential Oils on the Consumption of Benzodiazepine Receptor Agonists & Z-Drugs (BZRAs) Prescribed as " if Needed " in Psychiatric Outpatients (HECBA-PSY).
A Phase 4 study testing Essences and Essential Oils in people with Psychiatric Disorder and Benzodiazepine Withdrawal, run by Etablissement Public de Santé Barthélemy Durand at 1 site in France.
Trial summary
The goal of this interventional study is to test the use of olfactory Essential Oils through a nasal stick as one of the non-medicinal strategies to propose to the patient to reduce the consumption of medication in a population of stabilized patients with psychiatric disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychiatric Disorder, Benzodiazepine Withdrawal
- What is being tested?
- Essences and Essential Oils
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 19 Apr 2021to 30 Jul 2023
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult without legal protection measures
- Ambulatory followed up
- Stabilised main psychiatric pathology
- Patient having had recourse between 3 and 21 times a week in the previous 14 days to a benzodiazepine or related treatment, for anxiolytic or hypnotic purposes, prescribed "if necessary" (on request)
- Patient who understand French both orally and in writing
- Patient who do not have an identified organic cause for their disorder
- Patient who be affiliated to a social security scheme
- Patient who have given their free and informed consent and signed the consent form
Who cannot join
- Patients with asthma or unstable epilepsy
- Pregnancy or breastfeeding
- EO allergies
- Patients having already a regular consumption of EO for the study indication
- Patients under guardianship or under reinforced guardianship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Etablissement Public de Santé Barthélemy Durand
Étampes, 91150
Adelaide Aduayi, +33 1 75 02 16 81, adelaide.aduayi@eps-etampes.fr
Morgane Da Silva Hennequin, +33 1 82 26 81 08, morgane.dasilvahennequin@eps-etampes.fr
About this study
The goal of this interventional study is to test the use of olfactory Essential Oils through a nasal stick as one of the non-medicinal strategies to propose to the patient to reduce the consumption of medication in a population of stabilized patients with psychiatric disorder.
The main objective is to evaluate whether the olfaction of a mixture of essential oils can reduce the intake of BZRAs, prescribed if needed.
Read more
The investigators want to compare the number of medications prescribed on "if needed" basis before and after the introduction of Essential Oils.
A period prior to inclusion is used to assess the participant's frequency of BZRA use. Then, participants will received Essential Oils through a nasal stick during 4 weeks. During this period, the patient completes weekly anxiety and sleep scales and at the final visit, weekly and monthly anxiety and sleep scales.
Read the detailed description
It is a common in psychiatry for a physician to prescribe a patient, regardless of pathology, a treatment to be taken punctually in case of anxiety, nervousness, irritability or difficulty falling asleep. This "if needed" treatment can be add to the patient's usual treatment or constitute his only drug treatment.
Most of the time, the "if needed" medication prescribed is a BZRA, which exposes the patient to the risk of creating dependency and drug abuse if the doses are multiplied.
In this context, it seems interesting to us to test the use of olfactory Essential Oils through a nasal stick as one of the non-medicinal strategies to propose to the patient to reduce the consumption of medication.
A two-week period prior to inclusion is used to assess the patient's frequency of BZRA use.
During the pre-inclusion visit, the investigators explain the study protocol, the patient gives consent, and they are given a diary to record their BZRA use.
(one of the inclusion criteria is more than 3 and less than 21).
At the second visit, the patient fills out the anxiety and sleep questionnaire, the investigators perform an allergy test, and they receive an aromastick.
At following visits, the patient completes weekly anxiety and sleep scales and at the final visit, weekly and monthly anxiety and sleep scales.
- Conditions
- Psychiatric Disorder, Benzodiazepine Withdrawal
- Being tested
- Essences and Essential Oils
- Keywords
- Essential Oil, Psychiatry, Olfaction, Anxiety, Insomnia
- Medical subject headings
- Mental Disorders, Anosmia, Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essences and Essential OilsDrug
Participants will received Essential Oils through a nasal stick during 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Essential Oils | Experimental | Not described Receives: Drug: Essences and Essential Oils |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of medications prescribed
Compare the number of medications prescribed on "if needed" basis before and after the introduction of essential oils.
Measured: 4 weeks
Secondary outcomes (2)
Anxiety level
STAI (State Trait Anxiety Inventory) scale
Measured: 4 weeks
Sleep level
Pittsburgh Sleep Quality Index (PSQI) scale
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start19 Apr 2021
- Primary completion18 Apr 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Etablissement Public de Santé Barthélemy Durand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Trichard, Principal investigator, Etablissement Public de Santé Barthélemy Durand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583240
- Sponsor's protocol ID
- 21P01
- Other IDs
- 2019-A02345-52
- Acronym
- HECBA-PSY
- Status last verified
- Oct 2022
- First submitted
- 13 Oct 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Olfaction Essential Oils on the Consumption of Benzodiazepine Receptor Agonists & Z-Drugs (BZRAs) Prescribed as " if Needed " in Psychiatric Outpatients (HECBA-PSY).
- ClinicalTrials.gov ID
- NCT05583240
- Acronym / sponsor ID
- HECBA-PSY / 21P01
- Conditions
- Psychiatric Disorder, Benzodiazepine Withdrawal
- Keywords
- Essential Oil, Psychiatry, Olfaction, Anxiety, Insomnia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Etablissement Public de Santé Barthélemy DurandUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 18 Apr 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 17 Oct 2022 (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 goal of this interventional study is to test the use of olfactory Essential Oils through a nasal stick as one of the non-medicinal strategies to propose to the patient to reduce the consumption of medication in a population of stabilized patients with psychiatric disorder.
The main objective is to evaluate whether the olfaction of a mixture of essential oils can reduce the intake of BZRAs, prescribed if needed.
The investigators want to compare the number of medications prescribed on "if needed" basis before and after the introduction of Essential Oils.
A period prior to inclusion is used to assess the participant's frequency of BZRA use. Then, participants will received Essential Oils through a nasal stick during 4 weeks. During this period, the patient completes weekly anxiety and sleep scales and at the final visit, weekly and monthly anxiety and sleep scales.
Detailed description
It is a common in psychiatry for a physician to prescribe a patient, regardless of pathology, a treatment to be taken punctually in case of anxiety, nervousness, irritability or difficulty falling asleep. This "if needed" treatment can be add to the patient's usual treatment or constitute his only drug treatment.
Most of the time, the "if needed" medication prescribed is a BZRA, which exposes the patient to the risk of creating dependency and drug abuse if the doses are multiplied.
In this context, it seems interesting to us to test the use of olfactory Essential Oils through a nasal stick as one of the non-medicinal strategies to propose to the patient to reduce the consumption of medication.
A two-week period prior to inclusion is used to assess the patient's frequency of BZRA use.
During the pre-inclusion visit, the investigators explain the study protocol, the patient gives consent, and they are given a diary to record their BZRA use.
(one of the inclusion criteria is more than 3 and less than 21).
At the second visit, the patient fills out the anxiety and sleep questionnaire, the investigators perform an allergy test, and they receive an aromastick.
At following visits, the patient completes weekly anxiety and sleep scales and at the final visit, weekly and monthly anxiety and sleep scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Essential Oils | Experimental | Drug: Essences and Essential Oils |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult without legal protection measures
- Ambulatory followed up
- Stabilised main psychiatric pathology
- Patient having had recourse between 3 and 21 times a week in the previous 14 days to a benzodiazepine or related treatment, for anxiolytic or hypnotic purposes, prescribed "if necessary" (on request)
- Patient who understand French both orally and in writing
Key exclusion criteria (5 listed)
- Patients with asthma or unstable epilepsy
- Pregnancy or breastfeeding
- EO allergies
- Patients having already a regular consumption of EO for the study indication
- Patients under guardianship or under reinforced guardianship
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 |
|---|---|---|
| Essences and Essential OilsParticipants will received Essential Oils through a nasal stick during 4 weeks. | Drug | Essential Oils |
Primary outcome
Number of medications prescribed
Time frame: 4 weeks
Compare the number of medications prescribed on "if needed" basis before and after the introduction of essential oils.
2 secondary outcomes
Anxiety level
Time frame: 4 weeks
Sleep level
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Christian Trichard principal investigator
Etablissement Public de Santé Barthélemy Durand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Essences and Essential Oils in people with Psychiatric Disorder and Benzodiazepine Withdrawal, run by Etablissement Public de Santé Barthélemy Durand 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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Oct 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Adelaide Aduayi (+33 1 75 02 16 81, adelaide.aduayi@eps-etampes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of medications prescribed (time frame: 4 weeks). 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 18 Oct 2022.