Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Benzodiazepine Abuse
  • Benzodiazepine Dependence
  • Substance Use Disorders
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized controlled trialMasking: 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.Primary Purpose: Treatment

Participation Requirements

Age
Younger than 125 years
Gender
Both males and females

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 w...

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.

Tracking Information

NCT #
NCT04533230
Collaborators
Not Provided
Investigators
Principal Investigator: Johan Franck, MD, PhD Karolinska Institutet