Inappropriate PrescribingBENZOSTOPNCT06209827
Effectiveness of a Community Intervention in the Chronic Use of Benzodiazepines: (BENZOSTOPJUNTOS)
A study testing Intervention for reducing benzodiazepines long-term use. in people with Inappropriate Prescribing, run by Andalusian Health Service at 1 site in Spain.
Trial summary
This study aimed to assess the effectiveness of a comprehensive, multicomponent intervention utilizing education and support for Benzodiazepines withdrawal compared to standard care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inappropriate Prescribing
- What is being tested?
- Intervention for reducing benzodiazepines long-term use.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- users of health centre's with more than 4 weeks of benzodiazepines use.
- users of health centre's over 18 years of age.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Multidisciplinary Intervention in the Reduction of Benzodiazepine Prescriptions: A Cluster Controlled Trial
This study aimed to assess the effectiveness of a comprehensive, multicomponent intervention utilizing education and support for Benzodiazepines withdrawal compared to standard care.
Read the detailed description
The excessive use of benzodiazepines (BZDs) presents significant health concerns and high healthcare costs, particularly in Spain, where usage rates are among the highest globally. In Andalusian, over a 10% of the population use BZDs long-term, prompting the need for safe and effective reduction strategies.
This study aimed to assess the effectiveness of a comprehensive, multicomponent intervention utilizing education and support for BZD withdrawal compared to standard care.
The intervention involved educational discussions, consultations with health professionals, and letters supported by multiple scientific societies.
- Conditions
- Inappropriate Prescribing
- Being tested
- Intervention for reducing benzodiazepines long-term use.
- Keywords
- Benzodiazepine, Medication overuse., Inappropriate Prescribing
- Medical subject headings
- Prescription Drug Overuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention for reducing benzodiazepines long-term use.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Intervention for reducing benzodiazepines long-term use. |
| Usual Care | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of dispensing of benzodiazepines.
Number of dispensing of benzodiazepines, measured at the level of the participant.
Measured: 3.5 years
Secondary outcomes (2)
Knowledge
Knowledge: Empower questionary, measured at the level of the participant.
Measured: 6 months
Life Quality
Quality of life:Functional Status Measurement Sheets by coop World Organisation of Family Doctors (COOP/ WONCA):
The six COOP-WONCA Charts are described by vignettes and measured at the level of the participant: physical fitness, feelings, daily activities, social activities, change in health and overall health.
WONCA: World Organisation of Family Doctors
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Jan 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inappropriate PrescribingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- cluster-randomized, parallel-group trial in which health centres were the units of randomization and patients were the units of analysis
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andalusian Health Service
- Sponsor type
- Other government
- Collaborators
- Andalusian School of Public Health
- Responsible party
- Principal investigator, Ingrid Ferrer López, Andalusian Health Service
- Investigators
- Ingrid Ferrer López, Ph.D, Principal investigator, SAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209827
- Sponsor's protocol ID
- IFLBZD16
- Acronym
- BENZOSTOP
- Status last verified
- Jan 2024
- First submitted
- 6 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferrer Lopez I, Spacirova Z, Olry de Labry-Lima A, Gutierrez-Valencia A, Florencio Sayago M, Martinez Celdran M, Sumariva Bernal MA, Bermudez-Tamayo C. Cost-utility analysis of benzodiazepine deprescription in primary care: a cohort study. BMC Health Serv Res. 2026 Feb 17;26(1):390. doi: 10.1186/s12913-026-14149-2.
PubMed 41703502Ferrer 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.
PubMed 41142506
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multidisciplinary Intervention in the Reduction of Benzodiazepine Prescriptions: A Cluster Controlled Trial
- ClinicalTrials.gov ID
- NCT06209827
- Acronym / sponsor ID
- BENZOSTOP / IFLBZD16
- Conditions
- Inappropriate Prescribing
- Keywords
- Benzodiazepine, Medication overuse., Inappropriate Prescribing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- Andalusian Health ServiceOther government
- Collaborators
- Andalusian School of Public Health
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to assess the effectiveness of a comprehensive, multicomponent intervention utilizing education and support for Benzodiazepines withdrawal compared to standard care.
Detailed description
The excessive use of benzodiazepines (BZDs) presents significant health concerns and high healthcare costs, particularly in Spain, where usage rates are among the highest globally. In Andalusian, over a 10% of the population use BZDs long-term, prompting the need for safe and effective reduction strategies.
This study aimed to assess the effectiveness of a comprehensive, multicomponent intervention utilizing education and support for BZD withdrawal compared to standard care.
The intervention involved educational discussions, consultations with health professionals, and letters supported by multiple scientific societies.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- cluster-randomized, parallel-group trial in which health centres were the units of randomization and patients were the units of analysis
| Arm | Type | Receives |
|---|---|---|
| Intervention for reducing benzodiazepines long-term use. | Experimental | Behavioral: Intervention for reducing benzodiazepines long-term use.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. |
| Usual Care | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- users of health centre's with more than 4 weeks of benzodiazepines use.
- users of health centre's over 18 years of age.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention for reducing benzodiazepines long-term use.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. | Behavioural | Intervention for reducing benzodiazepines long-term use. |
Primary outcome
Number of dispensing of benzodiazepines.
Time frame: 3.5 years
Number of dispensing of benzodiazepines, measured at the level of the participant.
2 secondary outcomes
Knowledge
Time frame: 6 months
Life Quality
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Derived from this study: PubMed 41703502Ferrer Lopez I, Spacirova Z, Olry de Labry-Lima A, Gutierrez-Valencia A, Florencio Sayago M, Martinez Celdran M, Sumariva Bernal MA, Bermudez-Tamayo C. Cost-utility analysis of benzodiazepine deprescription in primary care: a cohort study. BMC Health Serv Res. 2026 Feb 17;26(1):390. doi: 10.1186/s12913-026-14149-2.
- Derived from this study: PubMed 41142506Ferrer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingrid Ferrer López, Ph.D principal investigator
SAS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention for reducing benzodiazepines long-term use. in people with Inappropriate Prescribing, run by Andalusian Health Service at 1 site in Spain.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of dispensing of benzodiazepines. (time frame: 3.5 years). 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 NCT06209827, which also lists 2 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 1 Feb 2024.