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New treatment option for Benzodiazepine Withdrawal
Official title Brief Motivational Intervention (BMI) on the Deprescription of Benzodiazepines and Related Substances in Adult Chronic Drug Users
ClinicalTrials.gov ID: NCT06446349
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 likely can't join if
- Concomitant treatment with:
- The following oral antipsychotics: risperidone, olanzapine, aripiprazole, quetiapine, clozapine, haloperidol, flupentixol, pimozide, chlorpromazine...
- 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
See the full eligibility 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
- Concomitant treatment with:
- The following oral antipsychotics: risperidone, olanzapine, aripiprazole, quetiapine, clozapine, haloperidol, flupentixol, pimozide, chlorpromazine, sulpiride, zuclopenthixol, loxapine, cyamemazine (\>100mg/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...
The study team makes the final eligibility decision.
Where it's taking place
- Annonay, France
- Auriol, France
- Beauvais, France
- Cap-d'Ail, France
- Castelnaudary, France
- Dolus-d'Oléron, France
- Dommartin, France
- Embrun, France
- Évenos, France
- Lavelanet, France
- Lentilly, France
- Ludres, France
- Marignane, France
- Marseille, France
- Moncoutant, France
- Saint-Georges-de-Reineins, France
- Saint-Omer, France
- Saint-Porchaire, France
- Savigné-l'Évêque, France
- Villemoisson-sur-Orge, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Annonay, France; Auriol, France; Beauvais, France; Cap-d'Ail, France; Castelnaudary, France; Dolus-d'Oléron, France and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.