Brief Motivational Intervention (BMI) on the Deprescription of Benzodiazepines and Related Substances in Adult Chronic Drug Users
NCT ID: NCT06446349
Last Updated: 2024-12-11
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
300 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-12-02
Study Completion Date
2026-12-01
Brief Summary
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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.
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.
Detailed Description
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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).
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).
Conditions
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Benzodiazepine Withdrawal
Keywords
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substance use disorder
community pharmacy
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Brief motivational intervention in community pharmacy
Primary Study Purpose
HEALTH_SERVICES_RESEARCH
Blinding Strategy
NONE
Study Groups
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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).
Group Type
EXPERIMENTAL
Brief motivational intervention
Intervention Type
OTHER
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).
Control
Standard of care in case of benzodiazepine prescription
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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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).
Intervention Type
OTHER
Eligibility Criteria
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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
* 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).
* 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).
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University Hospital, Grenoble
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Lucie PENNEL, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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Pharmacie Riffard Annonay
Annonay, , France
Site Status
RECRUITING
Pharmacie du Village
Auriol, , France
Site Status
RECRUITING
Pharmacie des Champs Dolent
Beauvais, , France
Site Status
RECRUITING
Pharmacie Troisgros
Cap-d'Ail, , France
Site Status
RECRUITING
Pharmacie des Fontanilles
Castelnaudary, , France
Site Status
RECRUITING
Pharmacie Dolus d'Oléron
Dolus-d'Oléron, , France
Site Status
RECRUITING
Pharmacie de Dommartin
Dommartin, , France
Site Status
RECRUITING
Pharmacie du Mont Guillaume
Embrun, , France
Site Status
RECRUITING
Ma Pharmacie Evenos
Évenos, , France
Site Status
RECRUITING
Pharmacie du Pog
Lavelanet, , France
Site Status
RECRUITING
Pharmacie de Lentilly
Lentilly, , France
Site Status
RECRUITING
Pharmacie Thomas
Ludres, , France
Site Status
RECRUITING
Pharmacie Saint Pierre Marignane
Marignane, , France
Site Status
RECRUITING
Pharmacie Milan Saint-Giniez
Marseille, , France
Site Status
RECRUITING
Pharmacie de la Sèvre
Moncoutant, , France
Site Status
RECRUITING
Pharmacie de St georges
Saint-Georges-de-Reineins, , France
Site Status
RECRUITING
Pharmacie du Théâtre
Saint-Omer, , France
Site Status
RECRUITING
Pharmacie du Château
Saint-Porchaire, , France
Site Status
RECRUITING
Pharmacie Labarrière
Savigné-l'Évêque, , France
Site Status
RECRUITING
Pharmacie de l'Ermitage
Villemoisson-sur-Orge, , France
Site Status
RECRUITING
Countries
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France
Central Contacts
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Facility Contacts
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Jean-Michel RIFFARD, PharmD
Role: primary
Morgane KERVEGANT, PharmD
Role: primary
Jean-Philippe EQUINET, PharmD
Role: primary
Elisabeth TROISGROS, PharmD
Role: primary
Isabelle SIBRA, PharmD
Role: primary
Agnès LALIS, PharmD
Role: primary
Luc MARCHAND, PharmD
Role: primary
Xavier BONO, PharmD
Role: primary
Nathalie DEBORD, PharmD
Role: primary
Fabrice PERILHOU, PharmD
Role: primary
Olivier DESCOUT, PharmD
Role: primary
Adrien Thomas, PharmD
Role: primary
Aurore ALLIONE, PharmD
Role: primary
Virginie ZURECKI, PharmD
Role: primary
Estelle DELABROYE, PharmD
Role: primary
Philippe BRUGERE, PharmD
Role: primary
Jean-Philippe SILVIE, PharmD
Role: primary
Alexandre PEYRIDIEUX, PharmD
Role: primary
Hervé LABARRIERE, PharmD
Role: primary
Mélanie SAROT, PharmD
Role: primary
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Related Links
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https://www.epi-phare.fr/rapports-detudes-et-publications/covid-19-usage-des-medicaments-rapport-6
Related Info
https://www.rfcrpv.fr/wp-content/uploads/2022/05/rapport-IATROSTAT-version-defintiive-02-mai-2022.pdf
Related Info
Other Identifiers
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2023-A01747-38
Identifier Type: OTHER
Identifier Source: secondary_id
38RC23.0198
Identifier Type: -
Identifier Source: org_study_id