Substance-Related Disorders Clinical Trial
— BENZORTOfficial title:
Exploring the Utility and Safety of Benzodiazepine Prescribing Among People Receiving Opiate Replacement Therapy in Scotland (the BENZORT Study).
NCT number | NCT04622995 |
Other study ID # | BENZORT |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2021 |
Est. completion date | December 31, 2022 |
Verified date | March 2023 |
Source | University of Stirling |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Drug-related deaths (DRD) are a significant and increasing public health problem in Scotland. Benzodiazepines and BZD-type substances (BZD) are increasingly implicated in DRD. In 2018, BZDs were implicated in 67% of DRD, often in combination with other illicit and prescribable substances including Opiate Replacement Therapies (ORT) such as methadone and buprenorphine. Illicit BZD use and dependence is higher among people with other substance use disorders. 29% of patients presenting to Scottish addiction services report current illicit BZD use. There is widespread variance in approaches to the clinical management of BZD dependence among people with opioid use disorder in Scotland. Some addiction clinicians are reluctant to prescribe BZD to people on ORT, some will prescribe BZD with the primary aim of dose reduction and detoxification, others will consider longer-term maintenance prescribing whilst patients stabilise on ORT. Previous research has identified increased risks of mortality among people taking BZD and ORT. Other work suggests that co-prescribing BZD and ORT increases patient engagement and retention in addiction treatment. This retrospective cohort study will analyse anonymised, linked data on people who received ORT between 01/01/2010 and 31/12/2020 to explore any relationships between exposure (co-prescribing of BZD and ORT) and harms including: mortality (all-cause and DRD), hospitalisation, illicit drug use during ORT, and reduced retention in addiction care.
Status | Completed |
Enrollment | 46899 |
Est. completion date | December 31, 2022 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years and older |
Eligibility | The cohort will consist of people who were prescribed ORT between 01/01/2010 and 31/12/2020. The definition of ORT is based on the following medications and associated British National Formulary (BNF) codes: Chemical (BNF code): Buprenorphine Hydrochloride/Naloxone Hydrochloride (0410030B0); Buprenorphine Hydrochloride (0410030A0); Methadone Hydrochloride (0410030C0) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | NHS Scotland | Edinburgh | Scotland |
Lead Sponsor | Collaborator |
---|---|
University of Stirling | NHS Research Scotland |
United Kingdom,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All-cause mortality | Death from any cause | From enrollment to end December 2020 | |
Secondary | Drug-related death | Fatal drug overdose | From enrollment to end December 2020 | |
Secondary | Drug overdose (non-fatal) | Non-fatal drug overdose | From enrollment to end December 2020 | |
Secondary | Hospitalisation | Admission to hospital from any cause | From enrollment to end December 2020 | |
Secondary | Evidence of illicit drug use during Opiate Substitution Therapy | Evidence of illicit drug use during Opiate Substitution Therapy | From enrollment to end December 2020 | |
Secondary | Retention in care | Retention in specialist addiction care for substance use disorder(s) | From enrollment to end December 2020 |
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