Brief Motivational Intervention (BMI) on the Deprescription of Benzodiazepines and Related Substances in Adult Chronic Drug Users
Recruiting now · Not applicable
Conditions studied: Benzodiazepine Withdrawal
In brief
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.
Key facts
- Study ID
- NCT06446349
- Run by
- University Hospital, Grenoble
- People needed
- 300
- Starts
- 2024-12-02
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2024-12-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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).
Where it is running
- Pharmacie des Champs Dolent — Beauvais, France (enrolling)
- Pharmacie Troisgros — Cap-d'Ail, France (enrolling)
- Pharmacie des Fontanilles — Castelnaudary, France (enrolling)
- Pharmacie Dolus d'Oléron — Dolus-d'Oléron, France (enrolling)
- Pharmacie de Dommartin — Dommartin, France (enrolling)
- Pharmacie du Mont Guillaume — Embrun, France (enrolling)
- Ma Pharmacie Evenos — Évenos, France (enrolling)
- Pharmacie du Pog — Lavelanet, France (enrolling)
- Pharmacie de Lentilly — Lentilly, France (enrolling)
- Pharmacie Thomas — Ludres, France (enrolling)
- Pharmacie Saint Pierre Marignane — Marignane, France (enrolling)
- Pharmacie Milan Saint-Giniez — Marseille, France (enrolling)
- Pharmacie de la Sèvre — Moncoutant, France (enrolling)
- Pharmacie de St georges — Saint-Georges-de-Reineins, France (enrolling)
- Pharmacie du Théâtre — Saint-Omer, France (enrolling)
- Pharmacie du Château — Saint-Porchaire, France (enrolling)
- Pharmacie Labarrière — Savigné-l'Évêque, France (enrolling)
- Pharmacie de l'Ermitage — Villemoisson-sur-Orge, France (enrolling)
- Pharmacie Riffard Annonay — Annonay, France (enrolling)
- Pharmacie du Village — Auriol, France (enrolling)
Full record on ClinicalTrials.gov
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