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NCT Number: NCT06446349

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pharmacie Riffard Annonay, Annonay, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Brief Motivational Intervention

Other

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).

Primary outcomes

  1. Change of the Daily dose of BZD/Z drug

    Time frame: 6 months

    Change of at least 50% of the Defined Daily Dose (DDD) initially prescribed (reduction), 6 months after the BPMI (during the last 4 weeks prior to the assessment)

  2. Worsening of the clinical symptoms of anxiety and/or sleep disorders

    Time frame: 6 months

    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.

Secondary outcomes

  1. 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

    Time frame: 12 months

    • Proportion of patients with a change (reduction) of at least 50% of the initially prescribed Defined Daily Dose (DDD), without clinical worsening, during the last 4 weeks prior to assessment.
  2. complete cessation of BZD/Z prescriptions without clinical worsening (superiority hypothesis) compared with the usual practice of dispensing BZD/Z in pharmacies

    Time frame: 6 months and 12 months

    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.

  3. declared consumption compared with the usual practice of dispensing BZD/Z in pharmacies

    Time frame: 6 months and 12 months

    declared average daily dose consumed and the number of days without consumption during the 7 days preceding the patient's visit

  4. anxiety symptoms

    Time frame: 12 months

    Worsening of anxiety at 12 months is considered to be an increase in anxiety ≥ 3 points on the Hospital anxiety and depression scale (HAD-A sub-score). HAD-A is from 0 (no anxiety) to 21(max of anxiety)

  5. depressive symptoms

    Time frame: 6 and 12 months

    A worsening of depression is considered to be an increase in depression ≥ 4 points on the Hospital anxiety and depression scale (HAD-D sub-score). HAD-D is from 0 (no depression) to 21 (max of depression)

  6. Worsening of severity of insomnia

    Time frame: 12 months

    A worsening of insomnia is considered to be an increase in insomnia ≥ 8 points on the Insomnia Severity Index (ISI). the score varies from 0 (no insomnia) to 21 (max of insomnia)

  7. transfers to other addictive products or behaviours

    Time frame: 6 and 12 months

    Evaluation of transfers to addictive products and/or behaviours on the "drugs" version of the Addictive Behaviour Intensity Questionnaire (QMICA). The score varies from 0 (no addictive behaviour) to 210 (max of addictive behaviour)

  8. misuse of BZD/Z

    Time frame: 6 and 12 months

    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.

  9. Adverse events description

    Time frame: 3, 6, 9 and 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Adeline PARIS, PharmD, PhD

CONTACT

[email protected]

+334 767 767 383

Lucie Pennel, MD, PhD

CONTACT

[email protected]

+33 670 386 149

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study 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

Acronym: BENZ_HALTE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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