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.
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
- Conditions the study is for
- Benzodiazepine Dependence, Benzodiazepine Abuse, Substance Use Disorders
- What is being tested?
- Educational intervention with prescription feedback and Information on treatment guidelines
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Educational intervention with prescription feedback | Experimental | The 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 guidelines | Active comparator | The 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 care | No intervention | The 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.
Prescriptions of benzodiazepines and benzodizepine-like hypnotics
Change in total prescriptions
Measured: 12 months
Secondary outcomes (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.
- First posted31 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Dec 2024 (estimated)
- 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
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benzodiazepine DependenceStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Franck, Karolinska Institutet
- Investigators
- Johan Franck, MD, PhD, Principal investigator, Karolinska Institutet
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.