Skip to content

Benzodiazepine stabilizing treatment for patients with benzodiazepine dependence undergoing opioid agonist therapy (BMX-BAR)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510404-44-02
Enrollment
108
Registered
2024-10-25
Start date
2022-10-02
Completion date
Unknown
Last updated
2025-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comorbid dependencies to benzodiazepines and opioids

Brief summary

The main endpoint is difference in the illegal index which measures the use of illicit benzodiazepines (as assessed by weekly or monthly supervised urinary tests) at week 24 compared to baseline. The illegal index is defined as the proportion of positive tests and is considered continuous.

Detailed description

Differences between the two study arms (baseline compared to week 24 in terms of: Mental health symptoms score using Hopkins symptom check list (SCL-10), Difference between the two study arms (baseline compared to week 24 in terms of: Reaction time (https://www.justpark.com/creative/reaction-time-test/), Differences between the two study arms (baseline compared to week 24 in terms of: Health related quality of life score using EQ-5D-5L, Differences between the two study arms in terms of: Satisfaction with the treatment using Visual Analogue Scale (VAS), Differences between the two study arms in terms of: Retention rate in OAT (days in treatment during the study period), Differences between the two study arms in terms of: Use of other illicit substances (stimulants, opioids, cannabis) and alcohol, based on urinary tests and self-reports, and illicit benzodiazepines based on self-reports, Differences between the two study arms in terms of: Violent behaviour and threats on violence, based on Brøset Violence checklist score (BVC), Differences between the two study arms in terms of: Numbers of non-fatal overdose and death (if any)

Interventions

DRUGValium 5 mg tabletter
DRUGSobril 15 mg tabletter
DRUGSobril 10 mg tabletter
DRUGStesolid
DRUGSobril 25 mg tabletter

Sponsors

Helse Bergen HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The main endpoint is difference in the illegal index which measures the use of illicit benzodiazepines (as assessed by weekly or monthly supervised urinary tests) at week 24 compared to baseline. The illegal index is defined as the proportion of positive tests and is considered continuous.

Secondary

MeasureTime frame
Differences between the two study arms (baseline compared to week 24 in terms of: Mental health symptoms score using Hopkins symptom check list (SCL-10), Difference between the two study arms (baseline compared to week 24 in terms of: Reaction time (https://www.justpark.com/creative/reaction-time-test/), Differences between the two study arms (baseline compared to week 24 in terms of: Health related quality of life score using EQ-5D-5L, Differences between the two study arms in terms of: Satisfaction with the treatment using Visual Analogue Scale (VAS), Differences between the two study arms in terms of: Retention rate in OAT (days in treatment during the study period), Differences between the two study arms in terms of: Use of other illicit substances (stimulants, opioids, cannabis) and alcohol, based on urinary tests and self-reports, and illicit benzodiazepines based on self-reports, Differences between the two study arms in terms of: Violent behaviour and threats on violence, based

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026