Brief Motivational Intervention (BMI) on the Deprescription of Benzodiazepines and Related Substances in Adult Chronic Drug Users (BENZ_HALTE)

December 5, 2024 updated by: University Hospital, Grenoble

Impact of Identification and Brief Motivational Intervention in Dispensing Pharmacies (BMI) on the Deprescription of Benzodiazepines and Related Substances in Adult Chronic Drug Users

We hypothesise that a short-term intervention by dispensing pharmacists is feasible and relatively easy to implement, and that it could have an impact on the deprescribing of BZD/Z in adult patients.

Two primary objectives will be evaluated in a sequential hierarchical manner, with two primary endpoints analysed one after the other, without alpha risk adjustment, but the second can only be analysed if the null hypothesis is rejected for the first:

  1. Evaluate the impact of brief motivational intervention (BMI) on reducing the daily dose of BZD/Z prescribed at 6 months (superiority hypothesis) compared with the usual practice of dispensing BZD/Z in pharmacies.
  2. Evaluate the impact of BMI on clinical worsening at 6 months (non-inferiority hypothesis) in comparison with the usual practice of dispensing BZD/Z in pharmacies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In France, the prevalence of use of benzodiazepines (BZDs) and related drugs (Z-drugs: zolpidem, zopiclone) (BZD/Z) was estimated at 13.4% in 2015, and 15% of new users had a first prescription exceeding the legal duration. The increase in prescriptions has continued to grow: in the first 4 months of 2021, an increase of 1.3 million anxiolytic treatments and 580,000 hypnotic treatments was observed, with new prescriptions for these treatments increasing by 15% for anxiolytics and 26% for hypnotics over the same year. The prevalence of long-term (>6 months) BZD prescriptions varies from country to country between 6% and 15% in the general population, and is estimated to reach 22% to 55% in people aged ≥ 65 years. In France, recommendations and good practice guidelines recommend prescriptions limited to 4 weeks for hypnotic BZD/Z and 12 weeks for anxiolytic BZD. However, a recent study focusing solely on anxiolytic BZDs, carried out in patients covered by the general social security system (excluding special schemes such as self-employed workers, farmers, etc.), showed that 12.2% of women and 9.3% of men aged over 50 were prescribed for longer than the legal duration.

All countries agree on the need to limit the length of time these drugs are prescribed because of the rapid inversion of the benefit/risk ratio in the case of prolonged and continuous prescribing (rapid loss of efficacy due to the tolerance effect associated with the occurrence of adverse effects.

A number of public health initiatives have been taken in France to reduce the initiation or continued use of long-term BZD/Z prescriptions, including information for healthcare professionals about the risks, pictograms on drug packaging, directives from the health authorities, incentives offered by the Assurance Maladie and regulatory measures to control prescribing. Alongside these measures, various types of psychosocial intervention are specifically aimed at deprescribing, defined as a clinically supervised process of stopping or reducing the dose of drugs when they cause harm or when the potential risks outweigh the benefits. These strategies have been evaluated for several years, ranging from brief interventions in the form of letters, self-support manuals and targeted consultations, to more complex psychotherapeutic interventions such as cognitive behavioural therapy (CBT) or pharmacological interventions.

Although complex interventions such as structured educational programmes or 3rd wave CBT have been shown to be effective in reducing long-term BZD/Z use, particularly in the elderly, they are often too long and complex to be implemented on a large scale, particularly in primary care, and all the more so in a context of increasing shortage of specialists. Brief interventions, which are both more realistic and functional, have been shown to be effective in reducing and stopping long-term use of BZD/Z at 6 and 12 months post-intervention. At the same time, very few studies have involved the active participation of pharmacy professionals. Yet the involvement of pharmacists would optimise prescribing, and a simple psychoeducation action carried out in pharmacies would have an economic impact. With a view to the shift to ambulatory care centred on the structuring of care pathways, increasing the skills of local pharmacists, as part of a multiprofessional coordination strategy, is a response to the requirements of the law modernising the French healthcare system, while offering a simple and pragmatic intervention model for patients whose prescriptions need to be optimised.

In this study, the investigators propose to evaluate the impact of identification combined with a brief motivational intervention in pharmacies (BMI) targeting the deprescription of BZD/Z in adult patients with long-term prescriptions (≥ 6 months).

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Annonay, France, 07100
        • Recruiting
        • Pharmacie Riffard Annonay
        • Contact:
          • Jean-Michel RIFFARD, PharmD
      • Auriol, France, 13390
        • Recruiting
        • Pharmacie du Village
        • Contact:
          • Morgane KERVEGANT, PharmD
      • Beauvais, France, 60000
        • Recruiting
        • Pharmacie des Champs Dolent
        • Contact:
          • Jean-Philippe EQUINET, PharmD
      • Cap-d'Ail, France, 06320
        • Recruiting
        • Pharmacie Troisgros
        • Contact:
          • Elisabeth TROISGROS, PharmD
      • Castelnaudary, France, 11400
        • Recruiting
        • Pharmacie des Fontanilles
        • Contact:
          • Isabelle SIBRA, PharmD
      • Dolus-d'Oléron, France, 17550
        • Recruiting
        • Pharmacie Dolus d'Oléron
        • Contact:
          • Agnès LALIS, PharmD
      • Dommartin, France, 69380
        • Recruiting
        • Pharmacie de Dommartin
        • Contact:
          • Luc MARCHAND, PharmD
      • Embrun, France, 05200
        • Recruiting
        • Pharmacie du Mont Guillaume
        • Contact:
          • Xavier BONO, PharmD
      • Lavelanet, France, 09300
        • Recruiting
        • Pharmacie du Pog
        • Contact:
          • Fabrice PERILHOU, PharmD
      • Lentilly, France, 69210
        • Recruiting
        • Pharmacie de Lentilly
        • Contact:
          • Olivier DESCOUT, PharmD
      • Ludres, France, 54710
        • Recruiting
        • Pharmacie Thomas
        • Contact:
          • Adrien Thomas, PharmD
      • Marignane, France, 13700
        • Recruiting
        • Pharmacie Saint Pierre Marignane
        • Contact:
          • Aurore ALLIONE, PharmD
      • Marseille, France, 13008
        • Recruiting
        • Pharmacie Milan Saint-Giniez
        • Contact:
          • Virginie ZURECKI, PharmD
      • Moncoutant, France, 79320
        • Recruiting
        • Pharmacie de la Sèvre
        • Contact:
          • Estelle DELABROYE, PharmD
      • Saint-Georges-de-Reineins, France, 69830
        • Recruiting
        • Pharmacie de St georges
        • Contact:
          • Philippe BRUGERE, PharmD
      • Saint-Omer, France, 62500
        • Recruiting
        • Pharmacie du Théâtre
        • Contact:
          • Jean-Philippe SILVIE, PharmD
      • Saint-Porchaire, France, 17250
        • Recruiting
        • Pharmacie du Château
        • Contact:
          • Alexandre PEYRIDIEUX, PharmD
      • Savigné-l'Évêque, France, 72460
        • Recruiting
        • Pharmacie Labarrière
        • Contact:
          • Hervé LABARRIERE, PharmD
      • Villemoisson-sur-Orge, France, 91360
        • Recruiting
        • Pharmacie de l'Ermitage
        • Contact:
          • Mélanie SAROT, PharmD
      • Évenos, France, 83330
        • Recruiting
        • Ma Pharmacie Evenos
        • Contact:
          • Nathalie DEBORD, PharmD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Continuous treatment (at least once daily) with BZD/Z for at least 6 months, after verification of 6 months' supply.
  • Signed informed consent
  • Patient able to understand the survey and complete a questionnaire in French.
  • Affiliation with the French social security system

Exclusion Criteria:

  • Concomitant treatment with:

    • The following oral antipsychotics: risperidone, olanzapine, aripiprazole, quetiapine, clozapine, haloperidol, flupentixol, pimozide, chlorpromazine, sulpiride, zuclopenthixol, loxapine, cyamemazine (>100mg/D), sulpiride (>150mg/D),
    • Injectable medium- and long-acting antipsychotics
    • Thymoregulatory treatment with lithium
    • Treatments for alcohol use disorders: baclofen, nalmefene, naltrexone, acamprosate, disulfiram
    • Opiate substitution treatments: buprenorphine, methadone
    • Anti-epileptic drugs
  • History of convulsions or epilepsy
  • History of gabaergic withdrawal accidents: delirium tremens, confusional syndrome requiring specialist treatment (hospitalisation, specialist consultation), epileptic seizures, etc.
  • Patients suffering from cancer
  • Persons referred to in articles L1121-5 to L1121-8 of the French Public Health Code (corresponding to all protected persons: pregnant women, women in childbirth, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brief motivational intervention
identification followed by a brief motivational intervention in pharmacies (BMI) based on the mobilisation of patients' psychosocial skills and the integration of tools to help reduce consumption of BZD/Z prescribed over the long term (≥ 6 months).
Other: Brief motivational intervention
identification followed by a brief motivational intervention in pharmacies (BMI) based on the mobilisation of patients' psychosocial skills and the integration of tools to help reduce consumption of BZD/Z prescribed over the long term (≥ 6 months).
No Intervention: Control
Standard of care in case of benzodiazepine prescription

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Worsening of the clinical symptoms of anxiety and/or sleep disorders
Time Frame: 6 months

Clinical worsening is defined as:

  • An increase in anxiety ≥ 3 points of the HAD-A sub-score (the minimum clinically significant difference being estimated at 3.2 +/- 4.
  • and/or an increase ≥ 8 points in the ISI (the minimum difference corresponding to a moderate improvement being estimated at > 7 points.
6 months
Change of the Daily dose of BZD/Z drug
Time Frame: 6 months
Change of at least 50% of the Defined Daily Dose (DDD) initially prescribed (reduction), 6 months after the BPMI (during the last 4 weeks prior to the assessment)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete cessation of BZD/Z prescriptions without clinical worsening (superiority hypothesis) compared with the usual practice of dispensing BZD/Z in pharmacies
Time Frame: 6 months and 12 months
Proportion of patients whose BZD/Z prescription was stopped, without clinical worsening. Discontinuation is defined as no prescriptions or dispensing identified in the last 4 weeks prior to assessment.
6 months and 12 months
declared consumption compared with the usual practice of dispensing BZD/Z in pharmacies
Time Frame: 6 months and 12 months
declared average daily dose consumed and the number of days without consumption during the 7 days preceding the patient's visit
6 months and 12 months
misuse of BZD/Z
Time Frame: 6 and 12 months
Assessment of misuse of BZD/Z. In the absence of a questionnaire specifically evaluating the misuse of benzodiazepine drugs, the evaluation is carried out in the form of open questions.
6 and 12 months
Adverse events description
Time Frame: 3, 6, 9 and 12 months
Description of all adverse events reported by patients during study follow-up. Specific monitoring of known severe adverse events related to the reduction in BZD/Z consumption, as well as falls, is carried out.
3, 6, 9 and 12 months
anxiety symptoms
Time Frame: 12 months
Worsening of anxiety at 12 months is considered to be an increase in anxiety ≥ 3 points on the Hospital anxiety and depression scale (HAD-A sub-score). HAD-A is from 0 (no anxiety) to 21(max of anxiety)
12 months
depressive symptoms
Time Frame: 6 and 12 months
A worsening of depression is considered to be an increase in depression ≥ 4 points on the Hospital anxiety and depression scale (HAD-D sub-score). HAD-D is from 0 (no depression) to 21 (max of depression)
6 and 12 months
Worsening of severity of insomnia
Time Frame: 12 months
A worsening of insomnia is considered to be an increase in insomnia ≥ 8 points on the Insomnia Severity Index (ISI). the score varies from 0 (no insomnia) to 21 (max of insomnia)
12 months
transfers to other addictive products or behaviours
Time Frame: 6 and 12 months
Evaluation of transfers to addictive products and/or behaviours on the "drugs" version of the Addictive Behaviour Intensity Questionnaire (QMICA). The score varies from 0 (no addictive behaviour) to 210 (max of addictive behaviour)
6 and 12 months
change of the prescribed daily dose of BZD/Z without clinical worsening (superiority hypothesis) compared with the usual practice of dispensing BZD/Z in pharmacies
Time Frame: 12 months
1. Proportion of patients with a change (reduction) of at least 50% of the initially prescribed Defined Daily Dose (DDD), without clinical worsening, during the last 4 weeks prior to assessment.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Lucie PENNEL, MD,PhD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 31, 2024

First Submitted That Met QC Criteria

May 31, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Estimated)

December 11, 2024

Last Update Submitted That Met QC Criteria

December 5, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC23.0198
  • 2023-A01747-38 (Other Identifier: ID RCB)

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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