Influence of Olfaction Essential Oils on the Consumption of Benzodiazepine Receptor Agonists & Z-Drugs (BZRAs) Prescribed as " if Needed " in Psychiatric Outpatients (HECBA-PSY).

NCT ID: NCT05583240

Last Updated: 2022-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-19
• Study Completion Date: 2023-07-30

Brief 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.

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.

Conditions

Psychiatric Disorder; Benzodiazepine Withdrawal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Essential Oils

Group Type: EXPERIMENTAL

Essences and Essential Oils

Intervention Type: DRUG

Participants will received Essential Oils through a nasal stick during 4 weeks.

Interventions

Essences and Essential Oils

Participants will received Essential Oils through a nasal stick during 4 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Etablissement Public de Santé Barthélemy Durand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Trichard

Role: PRINCIPAL_INVESTIGATOR

Etablissement Public de Santé Barthélemy Durand

Locations

Etablissement Public de Santé Barthélemy Durand

Étampes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Adelaide Aduayi

Role: CONTACT

adelaide.aduayi@eps-etampes.fr

+33 1 75 02 16 81

Morgane Da Silva Hennequin

Role: CONTACT

morgane.dasilvahennequin@eps-etampes.fr

+33 1 82 26 81 08

Facility Contacts

Adelaide Aduayi

Role: primary

adelaide.aduayi@eps-etampes.fr

+33 1 75 02 16 81

Morgane Da Silva Hennequin

Role: backup

morgane.dasilvahennequin@eps-etampes.fr

+33 1 82 26 81 08

Other Identifiers

2019-A02345-52

Identifier Type: REGISTRY

Identifier Source: secondary_id

21P01

Identifier Type: -

Identifier Source: org_study_id