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Prevention of Benzodiazepine Misuse in Primary Care

Prevention of Benzodiazepine Misuse: A Randomized Trial in Primary Care

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04533230
Enrollment
0
Registered
2020-08-31
Start date
2020-09-01
Completion date
2026-12-31
Last updated
2023-02-23

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

Conditions

Benzodiazepine Abuse, Benzodiazepine Dependence, Substance Use Disorders

Keywords

Primary Health Care, Benzodiazepines, Substance Use Disorder, Addiction, Prescription Drugs

Brief summary

Benzodiazepines and benzodiazepine-like hypnotics (z-drugs) are prevalent and addictive narcotics. Guidelines recommend restricted prescription of these drugs for anxiety and insomnia. The majority of benzodiazepine prescriptions are written for these disorders by physicians (GPs) in primary health care. Primary health care is thus an important arena for efforts to reduce access to benzodiazepines in order to lower the number of new users and users at risk of dependency. This trial evaluates whether a brief educational intervention in primary health care followed by 12 months of feedback on prescription data changes the prescription of benzodiazepines and benzodiazepine-like hypnotics.

Detailed description

Background: Benzodiazepines and the benzodiazepine-like hypnotics, often called z-drugs (hereafter benzodiazepines) are common and addictive narcotic drugs that can be obtained by prescription. Even short-term prescription can become a long-term problem, leading to tolerance and dependency, as well as adverse effects, including cognitive disturbance and decline, behavioral problems, emergency visits, accidents, suicide, and drug-related mortality. Guidelines restrict prescription of these drugs for anxiety and insomnia. The majority of benzodiazepine prescriptions are written for these disorders by physicians in primary health care. Primary health care is thus an important arena for efforts to reduce access to benzodiazepines in order to lower the number of new users and users at risk of dependency. Aim: This randomized controlled trial tests whether a brief educational intervention in primary health care followed by 12 months of feedback on prescription data changes prescriptions of benzodiazepines and benzodiazepine-like hypnotics. Methods: Primary health care centers will be invited to participate in the study. Centers that express interest in participating, meet the inclusion criteria, and do not meet the exclusion criteria will be randomized to the intervention or the control group. Personnel at the intervention centers will participate in a brief educational intervention followed by 12 months of regular feedback on benzodiazepine prescriptions that are written at the center. Personnel in an active control group will receive written information on treatment guidelines but will not receive the onsite educational intervention or prescription feedback. Data on characteristics of participating primary health care centers, as well as on prescriptions before the intervention and during and after the 12-month follow-up period, will be gathered from regional health care registers and databases and statistically analyzed.

Interventions

BEHAVIORALEducational intervention with prescription feedback

Educational intervention and targeted feedback on prescription of benzodiazepines and benzodiazepine-like hypnotics

BEHAVIORALInformation on treatment guidelines

Written information on treatment guidelines.

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Karolinska Trial Alliance (KTA) will conduct the randomization. The administrator at KTA who conducts the randomization will be blinded to the intervention.

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

for primary health care centers: * Employs at least two full-time physicians * Has at least 3000 patients * Has a regional care agreement (contract)

Exclusion criteria

for primary health care centers: * In operation for less than 12 months * Participated in an intervention to reduce benzodiazepine prescriptions in the last 12 months

Design outcomes

Primary

MeasureTime frameDescription
Prescriptions of benzodiazepines and benzodizepine-like hypnotics12 monthsChange in total prescriptions

Secondary

MeasureTime frameDescription
New prescriptions of benzodiazepines and benzodiazepine-like hypnotics12 monthsChange in new prescriptions

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026