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

Benzodiazepine Withdrawal Clinical Trial

— BENZ_HALTE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06446349
• Other study ID #: 38RC23.0198
• Secondary ID: 2023-A01747-38
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: August 1, 2026

Study information

• Verified date: May 2024
• Source: University Hospital, Grenoble
• Contact: Lucie Pennel, MD, PhD
• Phone: +33 670 386 149
• Email: LPennel[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

In France, the prevalence of use of benzodiazepines (BZDs) and related drugs (Z-drugs: zolpidem, zopiclone) (BZD/Z) was estimated at 13.4% in 2015, and 15% of new users had a first prescription exceeding the legal duration. The increase in prescriptions has continued to grow: in the first 4 months of 2021, an increase of 1.3 million anxiolytic treatments and 580,000 hypnotic treatments was observed, with new prescriptions for these treatments increasing by 15% for anxiolytics and 26% for hypnotics over the same year. The prevalence of long-term (>6 months) BZD prescriptions varies from country to country between 6% and 15% in the general population, and is estimated to reach 22% to 55% in people aged ≥ 65 years. In France, recommendations and good practice guidelines recommend prescriptions limited to 4 weeks for hypnotic BZD/Z and 12 weeks for anxiolytic BZD. However, a recent study focusing solely on anxiolytic BZDs, carried out in patients covered by the general social security system (excluding special schemes such as self-employed workers, farmers, etc.), showed that 12.2% of women and 9.3% of men aged over 50 were prescribed for longer than the legal duration. All countries agree on the need to limit the length of time these drugs are prescribed because of the rapid inversion of the benefit/risk ratio in the case of prolonged and continuous prescribing (rapid loss of efficacy due to the tolerance effect associated with the occurrence of adverse effects. A number of public health initiatives have been taken in France to reduce the initiation or continued use of long-term BZD/Z prescriptions, including information for healthcare professionals about the risks, pictograms on drug packaging, directives from the health authorities, incentives offered by the Assurance Maladie and regulatory measures to control prescribing. Alongside these measures, various types of psychosocial intervention are specifically aimed at deprescribing, defined as a clinically supervised process of stopping or reducing the dose of drugs when they cause harm or when the potential risks outweigh the benefits. These strategies have been evaluated for several years, ranging from brief interventions in the form of letters, self-support manuals and targeted consultations, to more complex psychotherapeutic interventions such as cognitive behavioural therapy (CBT) or pharmacological interventions. Although complex interventions such as structured educational programmes or 3rd wave CBT have been shown to be effective in reducing long-term BZD/Z use, particularly in the elderly, they are often too long and complex to be implemented on a large scale, particularly in primary care, and all the more so in a context of increasing shortage of specialists. Brief interventions, which are both more realistic and functional, have been shown to be effective in reducing and stopping long-term use of BZD/Z at 6 and 12 months post-intervention. At the same time, very few studies have involved the active participation of pharmacy professionals. Yet the involvement of pharmacists would optimise prescribing, and a simple psychoeducation action carried out in pharmacies would have an economic impact. With a view to the shift to ambulatory care centred on the structuring of care pathways, increasing the skills of local pharmacists, as part of a multiprofessional coordination strategy, is a response to the requirements of the law modernising the French healthcare system, while offering a simple and pragmatic intervention model for patients whose prescriptions need to be optimised. In this study, we propose to evaluate the impact of identification combined with a brief motivational intervention in pharmacies (BMI) targeting the deprescription of BZD/Z in adult patients with long-term prescriptions (≥ 6 months).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: August 1, 2026
• Est. primary completion date: February 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Benzodiazepine Withdrawal
• Drug Misuse

Intervention

Other:
• Brief motivational intervention
identification followed by a brief motivational intervention in pharmacies (BMI) based on the mobilisation of patients' psychosocial skills and the integration of tools to help reduce consumption of BZD/Z prescribed over the long term (= 6 months).

Locations

Country	Name	City	State
France	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	Ma Pharmacie Evenos	Évenos
France	Pharmacie du Pog	Lavelanet
France	Pharmacie de Lentilly	Lentilly
France	Pharmacie Thomas	Ludres
France	Pharmacie Saint Pierre Marignane	Marignane
France	Pharmacie Milan Saint-Giniez	Marseille
France	Pharmacie de la Sèvre	Moncoutant
France	Pharmacie du Théâtre	Saint-Omer
France	Pharmacie du Château	Saint-Porchaire
France	Pharmacie Fleur de Mai	Sanary-sur-Mer
France	Pharmacie Labarrière	Savigné-l'Évêque
France	Pharmacie de l'Ermitage	Villemoisson-sur-Orge

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

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* Note: There are 42 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy on reducing daily dose	reduction of at least 50% of the Defined Daily Dose (DDD) initially prescribed, 6 months after the BPMI (during the last 4 weeks prior to the assessment)	6 months
Primary	efficacy on clinical worsening	Clinical worsening is defined as: An increase in anxiety = 3 points of the HAD-A sub-score (the minimum clinically significant difference being estimated at 3.2 +/- 4.; and/or an increase = 8 points in the ISI (the minimum difference corresponding to a moderate improvement being estimated at > 7 points.	6 months
Secondary	reduction in the prescribed daily dose of BZD/Z without clinical worsening (superiority hypothesis) compared with the usual practice of dispensing BZD/Z in pharmacies	1. Proportion of patients with a reduction of at least 50% of the initially prescribed Defined Daily Dose (DDD), without clinical worsening, during the last 4 weeks prior to assessment.	12 months
Secondary	complete cessation of BZD/Z prescriptions without clinical worsening (superiority hypothesis) compared with the usual practice of dispensing BZD/Z in pharmacies	Proportion of patients whose BZD/Z prescription was stopped, without clinical worsening. Discontinuation is defined as no prescriptions or dispensing identified in the last 4 weeks prior to assessment.	6 months and 12 months
Secondary	declared consumption compared with the usual practice of dispensing BZD/Z in pharmacies	declared average daily dose consumed and the number of days without consumption during the 7 days preceding the patient's visit	6 months and 12 months
Secondary	anxiety symptoms	Worsening of anxiety at 12 months is considered to be an increase in anxiety = 3 points on the HAD-A sub-score.	12 months
Secondary	depressive symptoms	A worsening of depression is considered to be an increase in depression = 4 points on the HAD-D sub-score.	6 and 12 months
Secondary	severity of insomnia	A worsening of insomnia is considered to be an increase in insomnia = 8 points on the ISI.	12 months
Secondary	transfers to other addictive products or behaviours	Evaluation of transfers to addictive products and/or behaviours on the "drugs" version of the Addictive Behaviour Intensity Questionnaire (QMICA)	6 and 12 months
Secondary	misuse of BZD/Z	Assessment of misuse of BZD/Z. In the absence of a questionnaire specifically evaluating the misuse of benzodiazepine drugs, the evaluation is carried out in the form of open questions.	6 and 12 months
Secondary	Adverse events description	Description of all adverse events reported by patients during study follow-up. Specific monitoring of known severe adverse events related to the reduction in BZD/Z consumption, as well as falls, is carried out.	3, 6, 9 and 12 months

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