Motivational intervention to reduce benzodiazepine use in chronic drug users
Impact of Identification and Brief Motivational Intervention in Dispensing Pharmacies (BMI) on the Deprescription of Benzodiazepines and Related Substances in Adult Chronic Drug Users
This study is testing whether a short motivational talk from pharmacists can help adults who have been using benzodiazepines for a long time reduce their medication dosage and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 20 sites (Annonay and 19 other locations) |
| Trial ID | NCT06446349 on ClinicalTrials.gov |
What this trial studies
This intervention aims to evaluate the effectiveness of a brief motivational intervention (BMI) conducted by pharmacists to reduce the daily dosage of benzodiazepines and related substances (BZD/Z) in adult patients who have been using these medications for at least six months. The study will assess the impact of BMI on both the reduction of prescribed doses and the clinical outcomes of patients over a six-month period. The approach involves comparing the outcomes of patients receiving the BMI against those receiving standard dispensing practices in pharmacies. The study is set in France, where the prevalence of long-term BZD/Z prescriptions is a growing concern.
Who should consider this trial
Good fit: Ideal candidates are adults who have been on continuous treatment with benzodiazepines or related substances for at least six months.
Not a fit: Patients currently undergoing treatment with certain antipsychotics, mood stabilizers, or those with a history of severe withdrawal symptoms may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could lead to safer prescribing practices and improved health outcomes for patients dependent on benzodiazepines.
How similar studies have performed: While the approach of using motivational interventions in pharmacy settings is promising, this specific application to benzodiazepine deprescribing is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Annonay and 19 other locations
- Pharmacie Riffard Annonay — Annonay, France (Recruiting)
- Pharmacie du Village — Auriol, France (Recruiting)
- Pharmacie des Champs Dolent — Beauvais, France (Recruiting)
- Pharmacie Troisgros — Cap-d'Ail, France (Recruiting)
- Pharmacie des Fontanilles — Castelnaudary, France (Recruiting)
- Pharmacie Dolus d'Oléron — Dolus-d'Oléron, France (Recruiting)
- Pharmacie de Dommartin — Dommartin, France (Recruiting)
- Pharmacie du Mont Guillaume — Embrun, France (Recruiting)
- Ma Pharmacie Evenos — Évenos, France (Recruiting)
- Pharmacie du Pog — Lavelanet, France (Recruiting)
- Pharmacie de Lentilly — Lentilly, France (Recruiting)
- Pharmacie Thomas — Ludres, France (Recruiting)
- Pharmacie Saint Pierre Marignane — Marignane, France (Recruiting)
- Pharmacie Milan Saint-Giniez — Marseille, France (Recruiting)
- Pharmacie de la Sèvre — Moncoutant, France (Recruiting)
- Pharmacie de St georges — Saint-Georges-de-Reineins, France (Recruiting)
- Pharmacie du Théâtre — Saint-Omer, France (Recruiting)
- Pharmacie du Château — Saint-Porchaire, France (Recruiting)
- Pharmacie Labarrière — Savigné-l'Évêque, France (Recruiting)
- Pharmacie de l'Ermitage — Villemoisson-sur-Orge, France (Recruiting)
Study contacts
- Principal investigator: Lucie PENNEL, MD,PhD — University Hospital, Grenoble
- Study coordinator: Lucie Pennel, MD, PhD
- Email: LPennel@chu-grenoble.fr
- Phone: +33 670 386 149
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.