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

NCT06446349 | Recruiting

• 2 other identifiers: 38RC23.01982023-A01747-38
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 20

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. 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. 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.

Conditions

Benzodiazepine Withdrawal

Keywords

substance use disorder; community pharmacy

Outcome Measures

Primary Outcomes (2)

• 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)

  6 months

• 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.

  6 months

Secondary Outcomes (9)

• 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

  12 months

• complete cessation of BZD/Z prescriptions without clinical worsening (superiority hypothesis) compared with the usual practice of dispensing BZD/Z in pharmacies

  6 months and 12 months

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

  6 months and 12 months

• anxiety symptoms

  12 months

• depressive symptoms

  6 and 12 months

Study Arms (2)

Brief motivational intervention

EXPERIMENTAL

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).

Other: Brief motivational intervention

Control

NO INTERVENTION

Standard of care in case of benzodiazepine prescription

Interventions

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).

Brief motivational intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (20)

Pharmacie Riffard Annonay

Annonay, 07100, France

RECRUITING

Pharmacie du Village

Auriol, 13390, France

RECRUITING

Pharmacie des Champs Dolent

Beauvais, 60000, France

RECRUITING

Pharmacie Troisgros

Cap-d'Ail, 06320, France

RECRUITING

Pharmacie des Fontanilles

Castelnaudary, 11400, France

RECRUITING

Pharmacie Dolus d'Oléron

Dolus-d'Oléron, 17550, France

RECRUITING

Pharmacie de Dommartin

Dommartin, 69380, France

RECRUITING

Pharmacie du Mont Guillaume

Embrun, 05200, France

RECRUITING

Ma Pharmacie Evenos

Évenos, 83330, France

RECRUITING

Pharmacie du Pog

Lavelanet, 09300, France

RECRUITING

Pharmacie de Lentilly

Lentilly, 69210, France

RECRUITING

Pharmacie Thomas

Ludres, 54710, France

RECRUITING

Pharmacie Saint Pierre Marignane

Marignane, 13700, France

RECRUITING

Pharmacie Milan Saint-Giniez

Marseille, 13008, France

RECRUITING

Pharmacie de la Sèvre

Moncoutant, 79320, France

RECRUITING

Pharmacie de St georges

Saint-Georges-de-Reineins, 69830, France

RECRUITING

Pharmacie du Théâtre

Saint-Omer, 62500, France

RECRUITING

Pharmacie du Château

Saint-Porchaire, 17250, France

RECRUITING

Pharmacie Labarrière

Savigné-l'Évêque, 72460, France

RECRUITING

Pharmacie de l'Ermitage

Villemoisson-sur-Orge, 91360, France

RECRUITING

Related Publications (42)

• 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.

  PMID: 32860424 BACKGROUND

• 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.

  PMID: 34639523 BACKGROUND

• 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.

  PMID: 18058834 BACKGROUND

• 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.

  PMID: 26545257 BACKGROUND

• 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.

  PMID: 22800936 BACKGROUND

• 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.

  PMID: 30495993 BACKGROUND

• 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.

  PMID: 22536226 BACKGROUND

• 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.

  PMID: 10086433 BACKGROUND

• 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.

  PMID: 10674058 BACKGROUND

• 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.

  PMID: 31430394 BACKGROUND

• 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.

  PMID: 26106751 BACKGROUND

• 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.

  PMID: 31985127 BACKGROUND

• 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.

  PMID: 27354917 BACKGROUND

• 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.

  PMID: 34588769 BACKGROUND

• 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.

  PMID: 6880820 BACKGROUND

• Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.

  PMID: 21532953 BACKGROUND

• Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan AW, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014 Mar 7;348:g1687. doi: 10.1136/bmj.g1687.

  PMID: 24609605 BACKGROUND

• Sommer J, Rieder-Nakhle A, Gache P. [Brief motivational interventions in primary care]. Rev Med Suisse. 2007 Sep 26;3(126):2162-6. French.

  PMID: 17969733 BACKGROUND

• Gaume J, Grazioli VS, Paroz S, Fortini C, Bertholet N, Daeppen JB. Developing a brief motivational intervention for young adults admitted with alcohol intoxication in the emergency department - Results from an iterative qualitative design. PLoS One. 2021 Feb 8;16(2):e0246652. doi: 10.1371/journal.pone.0246652. eCollection 2021.

  PMID: 33556153 BACKGROUND

• Pottie K, Thompson W, Davies S, Grenier J, Sadowski CA, Welch V, Holbrook A, Boyd C, Swenson R, Ma A, Farrell B. Deprescription des agonistes des recepteurs des benzodiazepines: Lignes directrices de pratique clinique fondees sur les donnees probantes. Can Fam Physician. 2018 May;64(5):e209-e224. French.

  PMID: 29760269 BACKGROUND

• Cloatre E. Regulating Alternative Healing in France, And the Problem of 'Non-Medicine'. Med Law Rev. 2019 May 1;27(2):189-214. doi: 10.1093/medlaw/fwy024.

  PMID: 29955872 BACKGROUND

• Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007 Feb;28(2):182-91. doi: 10.1016/j.cct.2006.05.007. Epub 2006 Jul 7.

  PMID: 16829207 BACKGROUND

• Ohayon MM, Caulet M, Priest RG, Guilleminault C. Psychotropic medication consumption patterns in the UK general population. J Clin Epidemiol. 1998 Mar;51(3):273-83. doi: 10.1016/s0895-4356(97)00238-2.

  PMID: 9495693 BACKGROUND

• Neutel CI. The epidemiology of long-term benzodiazepine use. Int Rev Psychiatry. 2005 Jun;17(3):189-97. doi: 10.1080/09540260500071863.

  PMID: 16194790 BACKGROUND

• Lagnaoui R, Depont F, Fourrier A, Abouelfath A, Begaud B, Verdoux H, Moore N. Patterns and correlates of benzodiazepine use in the French general population. Eur J Clin Pharmacol. 2004 Sep;60(7):523-9. doi: 10.1007/s00228-004-0808-2.

  PMID: 15338086 BACKGROUND

• Olfson M, King M, Schoenbaum M. Benzodiazepine use in the United States. JAMA Psychiatry. 2015 Feb;72(2):136-42. doi: 10.1001/jamapsychiatry.2014.1763.

  PMID: 25517224 BACKGROUND

• Clay E, Falissard B, Moore N, Toumi M. Contribution of prolonged-release melatonin and anti-benzodiazepine campaigns to the reduction of benzodiazepine and Z-drugs consumption in nine European countries. Eur J Clin Pharmacol. 2013 Apr;69(4):1-10. doi: 10.1007/s00228-012-1424-1. Epub 2012 Nov 1.

  PMID: 23114457 BACKGROUND

• Schonfeld L, Hazlett RW, Hedgecock DK, Duchene DM, Burns LV, Gum AM. Screening, Brief Intervention, and Referral to Treatment for Older Adults With Substance Misuse. Am J Public Health. 2015 Jan;105(1):205-211. doi: 10.2105/AJPH.2013.301859.

  PMID: 24832147 BACKGROUND

• Vicens C, Bejarano F, Sempere E, Mateu C, Fiol F, Socias I, Aragones E, Palop V, Beltran JL, Pinol JL, Lera G, Folch S, Mengual M, Basora J, Esteva M, Llobera J, Roca M, Gili M, Leiva A. Comparative efficacy of two interventions to discontinue long-term benzodiazepine use: cluster randomised controlled trial in primary care. Br J Psychiatry. 2014 Jun;204(6):471-9. doi: 10.1192/bjp.bp.113.134650. Epub 2014 Feb 13.

  PMID: 24526745 BACKGROUND

• Ng BJ, Le Couteur DG, Hilmer SN. Deprescribing Benzodiazepines in Older Patients: Impact of Interventions Targeting Physicians, Pharmacists, and Patients. Drugs Aging. 2018 Jun;35(6):493-521. doi: 10.1007/s40266-018-0544-4.

  PMID: 29705831 BACKGROUND

• Tannenbaum C, Martin P, Tamblyn R, Benedetti A, Ahmed S. Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the EMPOWER cluster randomized trial. JAMA Intern Med. 2014 Jun;174(6):890-8. doi: 10.1001/jamainternmed.2014.949.

  PMID: 24733354 BACKGROUND

• Westbury J, Jackson S, Gee P, Peterson G. An effective approach to decrease antipsychotic and benzodiazepine use in nursing homes: the RedUSe project. Int Psychogeriatr. 2010 Feb;22(1):26-36. doi: 10.1017/S1041610209991128. Epub 2009 Oct 9.

  PMID: 19814843 BACKGROUND

• Faure G, Letoublon C, Clouye G, Guignier M, Marty F. [Value of arteriography in injuries of the kidney. The surgeon's viewpoint]. J Radiol Electrol Med Nucl. 1976 Aug-Sep;57(8-9):669-72. No abstract available. French.

  PMID: 978637 BACKGROUND

• Navy HJ, Weffald L, Delate T, Patel RJ, Dugan JP. Clinical Pharmacist Intervention to Engage Older Adults in Reducing Use of Alprazolam. Consult Pharm. 2018 Dec 1;33(12):711-722. doi: 10.4140/TCP.n.2018.711..

  PMID: 30545435 BACKGROUND

• Kreek MJ, LaForge KS, Butelman E. Pharmacotherapy of addictions. Nat Rev Drug Discov. 2002 Sep;1(9):710-26. doi: 10.1038/nrd897.

  PMID: 12209151 BACKGROUND

• Miller WR, Rollnick S. Ten things that motivational interviewing is not. Behav Cogn Psychother. 2009 Mar;37(2):129-40. doi: 10.1017/S1352465809005128.

  PMID: 19364414 BACKGROUND

• Cane J, O'Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci. 2012 Apr 24;7:37. doi: 10.1186/1748-5908-7-37.

  PMID: 22530986 BACKGROUND

• Atkins L, Francis J, Islam R, O'Connor D, Patey A, Ivers N, Foy R, Duncan EM, Colquhoun H, Grimshaw JM, Lawton R, Michie S. A guide to using the Theoretical Domains Framework of behaviour change to investigate implementation problems. Implement Sci. 2017 Jun 21;12(1):77. doi: 10.1186/s13012-017-0605-9.

  PMID: 28637486 BACKGROUND

• Yang M, Morin CM, Schaefer K, Wallenstein GV. Interpreting score differences in the Insomnia Severity Index: using health-related outcomes to define the minimally important difference. Curr Med Res Opin. 2009 Oct;25(10):2487-94. doi: 10.1185/03007990903167415.

  PMID: 19689221 BACKGROUND

• Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.

  PMID: 11438246 BACKGROUND

• Knisely JS, Wunsch MJ, Cropsey KL, Campbell ED. Prescription Opioid Misuse Index: a brief questionnaire to assess misuse. J Subst Abuse Treat. 2008 Dec;35(4):380-6. doi: 10.1016/j.jsat.2008.02.001. Epub 2008 Jul 26.

  PMID: 18657935 BACKGROUND

• Seppala LJ, Wermelink AMAT, de Vries M, Ploegmakers KJ, van de Glind EMM, Daams JG, van der Velde N; EUGMS task and Finish group on fall-risk-increasing drugs. Fall-Risk-Increasing Drugs: A Systematic Review and Meta-Analysis: II. Psychotropics. J Am Med Dir Assoc. 2018 Apr;19(4):371.e11-371.e17. doi: 10.1016/j.jamda.2017.12.098.

  PMID: 29402652 BACKGROUND

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MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Lucie PENNEL, MD,PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Brief motivational intervention in community pharmacy

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 6, 2024
• Study Start: December 2, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (20)