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

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.

Study Overview

• Status: Recruiting
• Conditions: Psychiatric Disorder; Benzodiazepine Withdrawal
• Intervention / Treatment: Drug: Essences and Essential Oils

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Adelaide Aduayi; Phone Number: +33 1 75 02 16 81; Email: adelaide.aduayi@eps-etampes.fr
• Study Contact Backup: Name: Morgane Da Silva Hennequin; Phone Number: +33 1 82 26 81 08; Email: morgane.dasilvahennequin@eps-etampes.fr

Study Locations

• France
  • Étampes, France, 91150
    • Recruiting
    • Etablissement Public de Santé Barthélemy Durand
    • Contact: Adelaide Aduayi; Phone Number: +33 1 75 02 16 81; Email: adelaide.aduayi@eps-etampes.fr
    • Contact: Morgane Da Silva Hennequin; Phone Number: +33 1 82 26 81 08; Email: morgane.dasilvahennequin@eps-etampes.fr
    • Principal Investigator: Christian Trichard
    • Sub-Investigator: Ioana Farcas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Essential Oils	Drug: Essences and Essential Oils; Participants will received Essential Oils through a nasal stick during 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of medications prescribed	Compare the number of medications prescribed on "if needed" basis before and after the introduction of essential oils.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety level	STAI (State Trait Anxiety Inventory) scale	4 weeks
Sleep level	Pittsburgh Sleep Quality Index (PSQI) scale	4 weeks

Collaborators and Investigators

• Sponsor: Etablissement Public de Santé Barthélemy Durand
• Investigators: Principal Investigator: Christian Trichard, Etablissement Public de Santé Barthélemy Durand

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2021
• Primary Completion (Anticipated): April 18, 2023
• Study Completion (Anticipated): July 30, 2023

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 15, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Anxiety; Insomnia; Psychiatry; Olfaction; Essential Oil
• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior; Mental Disorders
• Other Study ID Numbers: 21P01; 2019-A02345-52 (Registry Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No