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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Helse Bergen HF

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

2 Oct 2022 → ongoing

Decision date (initial)

2024-10-25

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-510404-44-02

EudraCT number

2021-004981-37

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To assess the impact of 24 weeks prescribed stable dose of diazepam or oxazepam versus 20 weeks tapering on illicit benzodiazepine use in benzodiazepine dependent patients undergoing OAT.

Secondary objectives 6

1. To assess the impact of stable dose of benzodiazepines on mental health
2. To assess the impact of stabel dose of benzodiazepines on physical health
3. To assess the impact of a stable dose of benzodiazepines on quality of life
4. To assess the impact of a stable dose of benzodiazepines on cognitive function
5. To assess the impact of a stable dose of benzodiazepines on comorbid substance use
6. To assess the impact of a stable dose of benzodiazepines on criminal activity

Conditions and MedDRA coding

Comorbid dependencies to benzodiazepines and opioids

Regulatory references

Plan to share IPD

Yes

IPD plan description

The data that will be shared: individual participant data that underlie the results, after deidentification (text, tables,figures, and appendices). Other documents that will be available: Study protocol When will data be available (start and end dates)? Beginning 9 months and ending 36 months following article publication. The data will be shared with: Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose. Types of analyses the data will be available for: For individual participant data meta-analysis. With what mechanism will data be made vailable: Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Adult age (≥ 18 years)
2. Opioid dependence according to ICD-10, and ongoing OAT
3. Benzodiazepine dependence according to ICD-10 under the following conditions: Minimum duration is the last 5 years Use 5-7 days a week during the last month Minimum dose used is equivalent to 15 mg diazepam/d or higher [21] Previous attempts with outpatient or inpatient tapering of benzodiazepines Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol The eligibility will be determined by clinical assessment with a medical doctor

Exclusion criteria 9

1. Severe respiratory failure (GOLD 3-4)
2. High risk of violent behavior (current violence episodes i.e., during the last 6 months)
3. High risk of substance related overdose (current overdoses i.e., during the last 6 months)
4. Severe cognitive impairment (IQ<70; assessed if needed based on clinical decision)
5. Severe psychosis (current psychotic symptoms and functioning i.e., during the last 6 months based on clinical decision)
6. Severe depression and high suicide risk (current episodes i.e., during the last 6 months based on clinical decision)
7. Patients who are already being stabilized with prescribed continuous benzodiazepines
8. Pregnancy and breastfeeding (It is a requirement that female participants use a safe method of contraception. In doubtful cases, a negative pregnancy test will be required)
9. Challenges related to ability to understand, consent, or willingness to collaborate in following-up of the study and its protocol

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 8

1. 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)
2. Difference between the two study arms (baseline compared to week 24 in terms of: Reaction time (https://www.justpark.com/creative/reaction-time-test/)
3. Differences between the two study arms (baseline compared to week 24 in terms of: Health related quality of life score using EQ-5D-5L
4. Differences between the two study arms in terms of: Satisfaction with the treatment using Visual Analogue Scale (VAS)
5. Differences between the two study arms in terms of: Retention rate in OAT (days in treatment during the study period)
6. 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
7. Differences between the two study arms in terms of: Violent behaviour and threats on violence, based on Brøset Violence checklist score (BVC)
8. Differences between the two study arms in terms of: Numbers of non-fatal overdose and death (if any)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Helse Bergen HF

Sponsor organisation

Helse Bergen HF

Address

Haukelandsveien 22

City

Bergen

Postcode

5021

Country

Norway

Scientific contact point

Organisation

Helse Bergen HF

Contact name

Fatemeh Chalabianloo

Public contact point

Organisation

Helse Bergen HF

Contact name

Fatemeh Chalabianloo

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 23 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications