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Benzodiazepine DependenceNCT04533230

Prevention of Benzodiazepine Misuse in Primary Care

A study testing Educational intervention with prescription feedback and Information on treatment guidelines in people with Benzodiazepine Dependence and Benzodiazepine Abuse, run by Karolinska Institutet at 1 site in Sweden.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Educational intervention with prescription feedback and Information on treatment guidelines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteSweden
Study dates
1 Sep 2020to 31 Dec 2026
Phase
Interventional

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Employs at least two full-time physicians
  • Has at least 3000 patients
  • Has a regional care agreement (contract)

Who cannot join

  • In operation for less than 12 months
  • Participated in an intervention to reduce benzodiazepine prescriptions in the last 12 months

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Region Stockholm, Academic primary health care center

    Stockholm, 104 31

Other trials in Sweden

About this study

Official title: Prevention of Benzodiazepine Misuse: A Randomized Trial in Primary Care

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.

Read the 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.

Being tested
Educational intervention with prescription feedback, Information on treatment guidelines
Keywords
Primary Health Care, Benzodiazepines, Substance Use Disorder, Addiction, Prescription Drugs
Medical subject headings
Substance-Related Disorders, Behavior, Addictive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational intervention with prescription feedbackBehavioural

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

  • Information on treatment guidelinesBehavioural

    Written information on treatment guidelines.

Study groups in NCT04533230
Study groupRoleWhat they receive
Educational intervention with prescription feedbackExperimentalThe manager and physicians at each intervention center will participate in a brief educational intervention about benzodiazepines and benzodiazepine-like hypnotics and receive 12 months of targeted feedback on prescription of these drugs. The education will cover national and regional treatment guidelines for anxiety, depression, and insomnia, which include guidelines on prescription of benzodiazepines and benzodiazepine-like hypnotics.
Receives: Behavioral: Educational intervention with prescription feedback
Information on guidelinesActive comparatorThe manager and physicians at each center in the active control group will receive written information on national and regional treatment guidelines for anxiety, depression, and insomnia, which include guidelines on prescription of benzodiazepines and benzodiazepine-like hypnotics. These centers will not receive the onsite educational intervention or 12 months of targeted prescription feedback.
Receives: Behavioral: Information on treatment guidelines
No active intervention: standard careNo interventionThe manager and physicians at each primary health care center in the passive control group will receive no active intervention. The passive control group will consist of primary health care centers that are not actively participating in the study. Data will be gathered from regional registers and databases. Thus, there will be no need to contact or communicate directly with the centers. This arm will be used only if the General Data Protection Regulation continues to allow access to regional registers and databases in primary health care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prescriptions of benzodiazepines and benzodizepine-like hypnotics

    Change in total prescriptions

    Measured: 12 months

Secondary outcomes (1)
  1. New prescriptions of benzodiazepines and benzodiazepine-like hypnotics

    Change in new prescriptions

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2020
  2. Study start1 Sep 2020 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Why it stopped: The study was stopped due to the COVID-19 pandemic restricting access to primary healthcare clinics.

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04533230
Sponsor's protocol ID
2018/1347-31/2
Status last verified
Feb 2023
First submitted
26 Aug 2020
Last updated
23 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data for this study will be gathered from regional registers and health care databases. For permission to access these data, interested parties should contact the regions.

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