Actively Recruiting
Brief Motivational Intervention (BMI) on the Deprescription of Benzodiazepines and Related Substances in Adult Chronic Drug Users
Led by University Hospital, Grenoble · Updated on 2024-12-11
300
Participants Needed
20
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Brief Motivational Intervention (BMI) on the Deprescription of Benzodiazepines and Related Substances in Adult Chronic Drug Users
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Continuous treatment with benzodiazepines or related drugs daily for at least 6 months
- Signed informed consent
- Ability to understand the survey and complete a questionnaire in French
- Affiliated with the French social security system
You will not qualify if you...
- Treatment with specific oral antipsychotics including risperidone, olanzapine, aripiprazole, quetiapine, clozapine, haloperidol, and others
- Treatment with injectable medium- or long-acting antipsychotics
- Treatment with lithium for mood stabilization
- Treatment for alcohol use disorders with baclofen, nalmefene, naltrexone, acamprosate, or disulfiram
- Opiate substitution treatments such as buprenorphine or methadone
- Use of anti-epileptic drugs
- History of convulsions or epilepsy
- History of severe withdrawal symptoms such as delirium tremens, confusional syndrome requiring specialist care, or epileptic seizures
- Diagnosis of cancer
- Protected persons under French Public Health Code articles L1121-5 to L1121-8 (including pregnant women, women in childbirth, nursing mothers, individuals deprived of liberty, or under legal protection)
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Trial Site Locations
Total: 20 locations
1
Pharmacie Riffard Annonay
Annonay, France, 07100
Actively Recruiting
2
Pharmacie du Village
Auriol, France, 13390
Actively Recruiting
3
Pharmacie des Champs Dolent
Beauvais, France, 60000
Actively Recruiting
4
Pharmacie Troisgros
Cap-d'Ail, France, 06320
Actively Recruiting
5
Pharmacie des Fontanilles
Castelnaudary, France, 11400
Actively Recruiting
6
Pharmacie Dolus d'Oléron
Dolus-d'Oléron, France, 17550
Actively Recruiting
7
Pharmacie de Dommartin
Dommartin, France, 69380
Actively Recruiting
8
Pharmacie du Mont Guillaume
Embrun, France, 05200
Actively Recruiting
9
Ma Pharmacie Evenos
Évenos, France, 83330
Actively Recruiting
10
Pharmacie du Pog
Lavelanet, France, 09300
Actively Recruiting
11
Pharmacie de Lentilly
Lentilly, France, 69210
Actively Recruiting
12
Pharmacie Thomas
Ludres, France, 54710
Actively Recruiting
13
Pharmacie Saint Pierre Marignane
Marignane, France, 13700
Actively Recruiting
14
Pharmacie Milan Saint-Giniez
Marseille, France, 13008
Actively Recruiting
15
Pharmacie de la Sèvre
Moncoutant, France, 79320
Actively Recruiting
16
Pharmacie de St georges
Saint-Georges-de-Reineins, France, 69830
Actively Recruiting
17
Pharmacie du Théâtre
Saint-Omer, France, 62500
Actively Recruiting
18
Pharmacie du Château
Saint-Porchaire, France, 17250
Actively Recruiting
19
Pharmacie Labarrière
Savigné-l'Évêque, France, 72460
Actively Recruiting
20
Pharmacie de l'Ermitage
Villemoisson-sur-Orge, France, 91360
Actively Recruiting
Research Team
L
Lucie Pennel, MD, PhD
CONTACT
A
Adeline PARIS, PharmD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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