Advancing the Science of Deprescribing: A Novel Comprehensive Conceptual Framework.
Amy Linsky, Walid F Gellad, Jeffrey A Linder...
https://pubmed.ncbi.nlm.nih.gov/31430394/Actively Recruiting
Led by University Hospital, Grenoble · Updated on 2024-12-11
300
Participants Needed
20
Research Sites
26 weeks
Total Duration
Researchers are evaluating the impact of a brief motivational intervention BMI delivered by pharmacists to help reduce the use of benzodiazepines and related drugs BZDZ in adults who have been taking these medications long-term at least 6 months. The study aims to see if this intervention can lower the daily dose of these drugs after 6 months without causing worsening of anxiety or sleep disorders, compared to usual pharmacy dispensing practices. This research takes place in the context of increasing prescriptions and concerns about prolonged use of BZDZ, which carry risks and potential adverse effects. Participants will either receive the BMI, which involves identification and a motivational approach that uses patients psychosocial skills and supporting tools to reduce BZDZ use, or continue with the standard practice of dispensing these medications in pharmacies. The intervention targets adults with chronic use of BZDZ, aiming for a practical and scalable method that pharmacists can apply during routine care. The study is randomized and does not use blinding. During the study, participants will be monitored over 6 and 12 months to assess changes in daily BZDZ doses, complete cessation rates, anxiety, depressive symptoms, insomnia severity, misuse, and any adverse events. Questionnaires and clinical evaluations will be used to measure outcomes at several points, including 3, 6, 9, and 12 months. The goal is to understand both the reduction in drug use and the clinical effects on patients symptoms and safety throughout the follow-up period.
CONDITIONS
Brief Motivational Intervention (BMI) on the Deprescription of Benzodiazepines and Related Substances in Adult Chronic Drug Users
L
Lucie Pennel, MD, PhD
A
Adeline PARIS, PharmD, PhD
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University Hospital, Grenoble
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session intervention with follow-up assessments up to 12 months
Participants receive identification and a brief motivational intervention in pharmacies to help reduce long-term use of benzodiazepines and related drugs.
Follow-up visits at 3, 6, 9, and 12 months post-intervention
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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Lead Sponsor