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

Sponsor: University Hospital, Grenoble • ClinicalTrials.gov ID: NCT06446349

Registry updated: 2026-10-02

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Description

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.

Interventions

Brief motivational intervention (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).

Eligibility criteria

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).

Conditions

Benzodiazepine Withdrawal

Locations

Pharmacie Riffard Annonay — Annonay, France
Pharmacie du Village — Auriol, France
Pharmacie des Champs Dolent — Beauvais, France
Pharmacie Troisgros — Cap-d'Ail, France
Pharmacie des Fontanilles — Castelnaudary, France
Pharmacie Dolus d'Oléron — Dolus-d'Oléron, France
Pharmacie de Dommartin — Dommartin, France
Pharmacie du Mont Guillaume — Embrun, France
Ma Pharmacie Evenos — Évenos, France
Pharmacie du Pog — Lavelanet, France
Pharmacie de Lentilly — Lentilly, France
Pharmacie Thomas — Ludres, France
Pharmacie Saint Pierre Marignane — Marignane, France
Pharmacie Milan Saint-Giniez — Marseille, France
Pharmacie de la Sèvre — Moncoutant, France
Pharmacie de St georges — Saint-Georges-de-Reineins, France
Pharmacie du Théâtre — Saint-Omer, France
Pharmacie du Château — Saint-Porchaire, France
Pharmacie Labarrière — Savigné-l'Évêque, France
Pharmacie de l'Ermitage — Villemoisson-sur-Orge, France

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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