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Benzodiazepine WithdrawalBENZ_HALTENCT06446349

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

A study testing Brief motivational intervention in people with Benzodiazepine Withdrawal, run by University Hospital, Grenoble at 20 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Benzodiazepine Withdrawal
What is being tested?
Brief motivational intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
20 sitesFrance
Study dates
3 Dec 2024to 3 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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).

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lucie Pennel, MD, PhD contact

+33 670 386 149

LPennel@chu-grenoble.fr

Adeline PARIS, PharmD, PhD contact

+334 767 767 383

aparis@chu-grenoble.fr

20 sites in 1 country

France20 sites, 20 recruiting

  • Pharmacie Riffard Annonay

    Annonay, 07100

    Jean-Michel RIFFARD, PharmD

    Recruiting

  • Pharmacie du Village

    Auriol, 13390

    Morgane KERVEGANT, PharmD

    Recruiting

  • Pharmacie des Champs Dolent

    Beauvais, 60000

    Jean-Philippe EQUINET, PharmD

    Recruiting

  • Pharmacie Troisgros

    Cap-d'Ail, 06320

    Elisabeth TROISGROS, PharmD

    Recruiting

  • Pharmacie des Fontanilles

    Castelnaudary, 11400

    Isabelle SIBRA, PharmD

    Recruiting

  • Pharmacie Dolus d'Oléron

    Dolus-d'Oléron, 17550

    Agnès LALIS, PharmD

    Recruiting

  • Pharmacie de Dommartin

    Dommartin, 69380

    Luc MARCHAND, PharmD

    Recruiting

  • Pharmacie du Mont Guillaume

    Embrun, 05200

    Xavier BONO, PharmD

    Recruiting

  • Ma Pharmacie Evenos

    Évenos, 83330

    Nathalie DEBORD, PharmD

    Recruiting

  • Pharmacie du Pog

    Lavelanet, 09300

    Fabrice PERILHOU, PharmD

    Recruiting

  • Pharmacie de Lentilly

    Lentilly, 69210

    Olivier DESCOUT, PharmD

    Recruiting

  • Pharmacie Thomas

    Ludres, 54710

    Adrien Thomas, PharmD

    Recruiting

  • Pharmacie Saint Pierre Marignane

    Marignane, 13700

    Aurore ALLIONE, PharmD

    Recruiting

  • Pharmacie Milan Saint-Giniez

    Marseille, 13008

    Virginie ZURECKI, PharmD

    Recruiting

  • Pharmacie de la Sèvre

    Moncoutant, 79320

    Estelle DELABROYE, PharmD

    Recruiting

  • Pharmacie de St georges

    Saint-Georges-de-Reineins, 69830

    Philippe BRUGERE, PharmD

    Recruiting

  • Pharmacie du Théâtre

    Saint-Omer, 62500

    Jean-Philippe SILVIE, PharmD

    Recruiting

  • Pharmacie du Château

    Saint-Porchaire, 17250

    Alexandre PEYRIDIEUX, PharmD

    Recruiting

  • Pharmacie Labarrière

    Savigné-l'Évêque, 72460

    Hervé LABARRIERE, PharmD

    Recruiting

  • Pharmacie de l'Ermitage

    Villemoisson-sur-Orge, 91360

    Mélanie SAROT, PharmD

    Recruiting

Other trials in France

About this study

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

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.
Read the 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).

Being tested
Brief motivational intervention
Keywords
substance use disorder, community pharmacy
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief motivational interventionOther

    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).

Study groups in NCT06446349
Study groupRoleWhat they receive
Brief motivational interventionExperimentalidentification 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).
Receives: Other: Brief motivational intervention
ControlNo interventionStandard of care in case of benzodiazepine prescription

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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)

    Measured: 6 months

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

    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.

    Measured: 6 months

Secondary outcomes (9)

  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

    1. 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.

    Measured: 12 months

  2. 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.

    Measured: 6 months and 12 months

  3. 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

    Measured: 6 months and 12 months

  4. anxiety symptoms

    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)

    Measured: 12 months

  5. depressive symptoms

    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)

    Measured: 6 and 12 months

  6. Worsening of severity of insomnia

    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)

    Measured: 12 months

  7. 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). The score varies from 0 (no addictive behaviour) to 210 (max of addictive behaviour)

    Measured: 6 and 12 months

  8. 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.

    Measured: 6 and 12 months

  9. 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.

    Measured: 3, 6, 9 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2024
  2. Study start3 Dec 2024
  3. Primary completion3 Apr 2027 (estimated)
  4. Study completion3 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Brief motivational intervention in community pharmacy
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06446349
Sponsor's protocol ID
38RC23.0198
Other IDs
2023-A01747-38
Acronym
BENZ_HALTE
Status last verified
Sep 2026
First submitted
31 May 2024
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Victorri-Vigneau C, Laforgue EJ, Grall-Bronnec M, Guillou-Landreat M, Rousselet M, Guerlais M; FAN-Network; Feuillet F, Jolliet P. Are Seniors Dependent on Benzodiazepines? A National Clinical Survey of Substance Use Disorder. Clin Pharmacol Ther. 2021 Feb;109(2):528-535. doi: 10.1002/cpt.2025. Epub 2020 Sep 23.

    PubMed 32860424

  • Chapoutot M, Peter-Derex L, Bastuji H, Leslie W, Schoendorff B, Heinzer R, Siclari F, Nicolas A, Lemoine P, Higgins S, Bourgeois A, Vallet GT, Anders R, Ounnoughene M, Spencer J, Meloni F, Putois B. Cognitive Behavioral Therapy and Acceptance and Commitment Therapy for the Discontinuation of Long-Term Benzodiazepine Use in Insomnia and Anxiety Disorders. Int J Environ Res Public Health. 2021 Sep 28;18(19):10222. doi: 10.3390/ijerph181910222.

    PubMed 34639523

  • Cheng JS, Huang WF, Lin KM, Shih YT. Characteristics associated with benzodiazepine usage in elderly outpatients in Taiwan. Int J Geriatr Psychiatry. 2008 Jun;23(6):618-24. doi: 10.1002/gps.1950.

    PubMed 18058834

  • Kurko TA, Saastamoinen LK, Tahkapaa S, Tuulio-Henriksson A, Taiminen T, Tiihonen J, Airaksinen MS, Hietala J. Long-term use of benzodiazepines: Definitions, prevalence and usage patterns - a systematic review of register-based studies. Eur Psychiatry. 2015 Nov;30(8):1037-47. doi: 10.1016/j.eurpsy.2015.09.003. Epub 2015 Nov 4.

    PubMed 26545257

  • Preville M, Bosse C, Vasiliadis HM, Voyer P, Laurier C, Berbiche D, Perodeau G, Grenier S, Beland SG, Dionne PA, Gentil L, Moride Y. Correlates of potentially inappropriate prescriptions of benzodiazepines among older adults: results from the ESA study. Can J Aging. 2012 Sep;31(3):313-22. doi: 10.1017/S0714980812000232. Epub 2012 Jul 17.

    PubMed 22800936

  • Airagnes G, Lemogne C, Olekhnovitch R, Roquelaure Y, Hoertel N, Goldberg M, Limosin F, Zins M. Work-Related Stressors and Increased Risk of Benzodiazepine Long-Term Use: Findings From the CONSTANCES Population-Based Cohort. Am J Public Health. 2019 Jan;109(1):119-125. doi: 10.2105/AJPH.2018.304734. Epub 2018 Nov 29.

    PubMed 30495993

  • Vinkers CH, Olivier B. Mechanisms Underlying Tolerance after Long-Term Benzodiazepine Use: A Future for Subtype-Selective GABA(A) Receptor Modulators? Adv Pharmacol Sci. 2012;2012:416864. doi: 10.1155/2012/416864. Epub 2012 Mar 29.

    PubMed 22536226

  • Morin CM, Colecchi C, Stone J, Sood R, Brink D. Behavioral and pharmacological therapies for late-life insomnia: a randomized controlled trial. JAMA. 1999 Mar 17;281(11):991-9. doi: 10.1001/jama.281.11.991.

    PubMed 10086433

  • Holbrook AM, Crowther R, Lotter A, Cheng C, King D. The diagnosis and management of insomnia in clinical practice: a practical evidence-based approach. CMAJ. 2000 Jan 25;162(2):216-20.

    PubMed 10674058

  • Linsky A, Gellad WF, Linder JA, Friedberg MW. Advancing the Science of Deprescribing: A Novel Comprehensive Conceptual Framework. J Am Geriatr Soc. 2019 Oct;67(10):2018-2022. doi: 10.1111/jgs.16136. Epub 2019 Aug 20.

    PubMed 31430394

  • Darker CD, Sweeney BP, Barry JM, Farrell MF, Donnelly-Swift E. Psychosocial interventions for benzodiazepine harmful use, abuse or dependence. Cochrane Database Syst Rev. 2015;2015(5):CD009652. doi: 10.1002/14651858.CD009652.pub2.

    PubMed 26106751

  • Lynch T, Ryan C, Hughes CM, Presseau J, van Allen ZM, Bradley CP, Cadogan CA. Brief interventions targeting long-term benzodiazepine and Z-drug use in primary care: a systematic review and meta-analysis. Addiction. 2020 Sep;115(9):1618-1639. doi: 10.1111/add.14981. Epub 2020 Feb 11.

    PubMed 31985127

  • Riordan DO, Walsh KA, Galvin R, Sinnott C, Kearney PM, Byrne S. The effect of pharmacist-led interventions in optimising prescribing in older adults in primary care: A systematic review. SAGE Open Med. 2016 Jun 14;4:2050312116652568. doi: 10.1177/2050312116652568. eCollection 2016.

    PubMed 27354917

  • Buzancic I, Dragovic P, Pejakovic TI, Markulin L, Ortner-Hadziabdic M. Exploring Patients' Attitudes Toward Deprescribing and Their Perception of Pharmacist Involvement in a European Country: A Cross-Sectional Study. Patient Prefer Adherence. 2021 Sep 23;15:2197-2208. doi: 10.2147/PPA.S323846. eCollection 2021.

    PubMed 34588769

  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PubMed 6880820

Questions about this trial

What is this clinical trial studying?

A study testing Brief motivational intervention in people with Benzodiazepine Withdrawal, run by University Hospital, Grenoble at 20 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lucie Pennel, MD, PhD (+33 670 386 149, LPennel@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of the Daily dose of BZD/Z drug (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06446349, which also lists 42 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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