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

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Grenoble
NCT06446349 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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).
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What it tests

  • Brief motivational intervention
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Where

20 sites
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

…and 12 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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