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Clinical trial on the efficacy of two interventions for discontinuing long term benzodiazepine use in primary care

A cluster randomised controlled trial on the efficacy of a structured educational intervention or minimal intervention versus usual care for discontinuing long term benzodiazepine use in primary care

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13024375
Enrollment
495
Registered
2010-07-27
Start date
2010-07-15
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benzodiazepine use, reduction and withdrawal Mental and Behavioural Disorders

Interventions

Patients were randomised to one of three groups, comparing two strategies for the reduction of chronic bendzodizepine and a control group: 1. Structured educational intervention: 1 educational intervi

Sponsors

Health Service of the Balearic Islands (Servei de Salut de les Illes Balears [IB-salut]) (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients between 18 and 80 years 2. Recorded history of benzodiazepine consumption or an analogue at least 5 times a week for at least six months 3. A minimum of 6 months prescription of a benzodiazepine or similar

Exclusion criteria

Exclusion criteria: 1. Patients with severe anxiety or depressive disorder, psychotic disorder, severe personality disorder, and/or psychiatric monitoring 2. Patients with cognitive impairment, terminal illness or serious medical conditions, illegal drug use or abuse alcohol, inability to sign informed consent 3. Institutionalised patients 4. Patients with exacerbation of symptoms of anxiety/depression whose doctor considers that the withdrawal of a benzodiazepine can be harmful at this time 5. Patients with limited capacity for understanding 6. Patients that have participated in a clinical research study during the last 3 months

Design outcomes

Primary

MeasureTime frame
Benzodiazepine use at 12 months

Secondary

MeasureTime frame
1. Anxiety and Depression Scale 2. Quality of Sleep Scale 3. Alcohol consumption Outcomes will be measured at baseline, 6 and 12 months.

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 29, 2026