NCT06209827

Brief Summary

This study aimed to assess the effectiveness of a comprehensive, multicomponent intervention utilizing education and support for Benzodiazepines withdrawal compared to standard care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
472

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

4 years

First QC Date

January 6, 2024

Last Update Submit

January 31, 2024

Conditions

Inappropriate Prescribing

Keywords

BenzodiazepineMedication overuse.Inappropriate Prescribing

Outcome Measures

Primary Outcomes (1)

  • Number of dispensing of benzodiazepines.

    Number of dispensing of benzodiazepines, measured at the level of the participant.

    3.5 years

Secondary Outcomes (2)

  • Knowledge

    6 months

  • Life Quality

    6 months

Study Arms (2)

Intervention for reducing benzodiazepines long-term use.

EXPERIMENTAL

It included the multiple components as follows: (i) an exchange discussion with the patient describing the advantages, disadvantages and alternatives of benzodiazepines use and a tapering protocol with the support of educational material, (ii) the offer of a brief, if necessary, consultation with the family doctor, and (iii) a letter addressed to the patient supported by scientific societies.

Behavioral: Intervention for reducing benzodiazepines long-term use.

Usual Care

NO INTERVENTION

Usual Care

Interventions

Intervention for reducing benzodiazepines long-term use.BEHAVIORAL

Comprehensive, multicomponent intervention utilizing education and support for benzodiazepines. Family doctor, nurse, community pharmacist and social workers: carried out informative discussion with the patient with by providing educational material. They informed patients about the advantages, disadvantages and alternatives to benzodiazepines including a descending benzodiazepines schedule to minimize withdrawal symptoms. It briefly explained the professionals' concerns about the continued use of benzodiazepines and offers possible solutions. If the patient requested a withdrawal, he/she was referred to the doctor.

Intervention for reducing benzodiazepines long-term use.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • users of health centre's with more than 4 weeks of benzodiazepines use.
  • users of health centre's over 18 years of age.

You may not qualify if:

  • users of health centre's with mental disorder.
  • users of health centre's terminal.
  • users of health centre's with alcohol dependence.
  • users of health centre's with dementia.
  • users of health centre's who had intellectual disabilities.
  • users of health centre's unable to cooperate with the questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ingrid Ferrer López

Seville, 41011, Spain

Location

Related Publications (1)

  • Ferrer Lopez I, Olry de Labry-Lima A, Gutierrez-Valencia A, Garcia Bermudez E, Atienza Martin F, Morente AG, Murillo Fernandez MD, Sanchez Canete Y, Bermudez-Tamayo C. Risk perception, attitudes, and quality of life in a multicomponent benzodiazepine deprescription strategy. Explor Res Clin Soc Pharm. 2025 Sep 30;20:100666. doi: 10.1016/j.rcsop.2025.100666. eCollection 2025 Dec.

    PMID: 41142506DERIVED

MeSH Terms

Conditions

Prescription Drug Overuse

Interventions

Methods

Condition Hierarchy (Ancestors)

Prescription Drug MisuseDrug MisuseSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Ingrid Ferrer López, Ph.D

    SAS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data collector was not involved in outcomes assessment.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: cluster-randomized, parallel-group trial in which health centres were the units of randomization and patients were the units of analysis
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator. Primary Care Pharmacist. Pharm.G, Ph.D. Clinical management unit Primary care pharmacy Seville.Andalusian Health Service

Study Record Dates

First Submitted

January 6, 2024

First Posted

January 18, 2024

Study Start

January 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)