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

Last updated: December 5, 2024
Sponsor: University Hospital, Grenoble
Overall Status: Active - Recruiting

Phase

N/A

Condition

Opioid Use Disorder

Drug Use

Treatment

Brief motivational intervention

Clinical Study ID

NCT06446349
38RC23.0198
2023-A01747-38
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Continuous treatment (at least once daily) with BZD/Z for at least 6 months, afterverification 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

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 syndromerequiring specialist treatment (hospitalisation, specialist consultation), epilepticseizures, 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 administrativedecision, persons subject to a legal protection measure).

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Brief motivational intervention
Phase:
Study Start date:
December 02, 2024
Estimated Completion Date:
December 01, 2026

Study 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).

Connect with a study center

  • Pharmacie Riffard Annonay

    Annonay, 07100
    France

    Active - Recruiting

  • Pharmacie du Village

    Auriol, 13390
    France

    Active - Recruiting

  • Pharmacie des Champs Dolent

    Beauvais, 60000
    France

    Active - Recruiting

  • Pharmacie Troisgros

    Cap-d'Ail, 06320
    France

    Active - Recruiting

  • Pharmacie des Fontanilles

    Castelnaudary, 11400
    France

    Active - Recruiting

  • Pharmacie Dolus d'Oléron

    Dolus-d'Oléron, 17550
    France

    Active - Recruiting

  • Pharmacie de Dommartin

    Dommartin, 69380
    France

    Active - Recruiting

  • Pharmacie du Mont Guillaume

    Embrun, 05200
    France

    Active - Recruiting

  • Pharmacie du Pog

    Lavelanet, 09300
    France

    Active - Recruiting

  • Pharmacie de Lentilly

    Lentilly, 69210
    France

    Active - Recruiting

  • Pharmacie Thomas

    Ludres, 54710
    France

    Active - Recruiting

  • Pharmacie Saint Pierre Marignane

    Marignane, 13700
    France

    Active - Recruiting

  • Pharmacie Milan Saint-Giniez

    Marseille, 13008
    France

    Active - Recruiting

  • Pharmacie de la Sèvre

    Moncoutant, 79320
    France

    Active - Recruiting

  • Pharmacie de St georges

    Saint-Georges-de-Reineins, 69830
    France

    Active - Recruiting

  • Pharmacie du Théâtre

    Saint-Omer, 62500
    France

    Active - Recruiting

  • Pharmacie du Château

    Saint-Porchaire, 17250
    France

    Active - Recruiting

  • Pharmacie Fleur de Mai

    Sanary-sur-Mer, 83110
    France

    Site Not Available

  • Pharmacie Labarrière

    Savigné-l'Évêque, 72460
    France

    Active - Recruiting

  • Pharmacie de l'Ermitage

    Villemoisson-sur-Orge, 91360
    France

    Active - Recruiting

  • Ma Pharmacie Evenos

    Évenos, 83330
    France

    Active - Recruiting

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