Clinical trial NCT06446349: Brief Motivational Intervention (BMI) on the Deprescription of Benzodiazepines and Related Substances in Adult Chronic Drug Users
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benzodiazepine Withdrawal
Keywords: substance use disorder
community pharmacy
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Brief motivational intervention in community pharmacy
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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, the investigators 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).

Eligibility 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).

Primary outcomes:
measure: Change of the Daily dose of BZD/Z drug
timeFrame: 6 months
measure: Worsening of the clinical symptoms of anxiety and/or sleep disorders
timeFrame: 6 months
Secondary outcomes:
measure: change of the prescribed daily dose of BZD/Z without clinical worsening (superiority hypothesis) compared with the usual practice of dispensing BZD/Z in pharmacies
timeFrame: 12 months
measure: complete cessation of BZD/Z prescriptions without clinical worsening (superiority hypothesis) compared with the usual practice of dispensing BZD/Z in pharmacies
timeFrame: 6 months and 12 months
measure: declared consumption compared with the usual practice of dispensing BZD/Z in pharmacies
timeFrame: 6 months and 12 months
measure: anxiety symptoms
timeFrame: 12 months
measure: depressive symptoms
timeFrame: 6 and 12 months
measure: Worsening of severity of insomnia
timeFrame: 12 months
measure: transfers to other addictive products or behaviours
timeFrame: 6 and 12 months
measure: misuse of BZD/Z
timeFrame: 6 and 12 months
measure: Adverse events description
timeFrame: 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Annonay
country: France
facility: Pharmacie Riffard Annonay
city: Auriol
country: France
facility: Pharmacie du Village
city: Beauvais
country: France
facility: Pharmacie des Champs Dolent
city: Cap-d'Ail
country: France
facility: Pharmacie Troisgros
city: Castelnaudary
country: France
facility: Pharmacie des Fontanilles
city: Dolus-d'Oléron
country: France
facility: Pharmacie Dolus d'Oléron
city: Dommartin
country: France
facility: Pharmacie de Dommartin
city: Embrun
country: France
facility: Pharmacie du Mont Guillaume
city: Lavelanet
country: France
facility: Pharmacie du Pog
city: Lentilly
country: France
facility: Pharmacie de Lentilly
city: Ludres
country: France
facility: Pharmacie Thomas
city: Marignane
country: France
facility: Pharmacie Saint Pierre Marignane
city: Marseille
country: France
facility: Pharmacie Milan Saint-Giniez
city: Moncoutant
country: France
facility: Pharmacie de la Sèvre
city: Saint-Georges-de-Reineins
country: France
facility: Pharmacie de St georges
city: Saint-Omer
country: France
facility: Pharmacie du Théâtre
city: Saint-Porchaire
country: France
facility: Pharmacie du Château
city: Savigné-l'Évêque
country: France
facility: Pharmacie Labarrière
city: Villemoisson-sur-Orge
country: France
facility: Pharmacie de l'Ermitage
city: Évenos
country: France
facility: Ma Pharmacie Evenos
Study officials:
affiliation: University Hospital, Grenoble
name: Lucie PENNEL, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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