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Benzodiazepine stabilizing treatment for patients with benzodiazepine dependence undergoing opioid agonist therapy (BMX-BAR)
EU CTIS ID: 2023-510404-44-02
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult age (≥ 18 years)
- Opioid dependence according to ICD-10, and ongoing OAT
- 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
You likely can't join if
- Severe respiratory failure (GOLD 3-4)
- High risk of violent behavior (current violence episodes i.e., during the last 6 months)
- High risk of substance related overdose (current overdoses i.e., during the last 6 months)
- Severe cognitive impairment (IQ<70; assessed if needed based on clinical decision)
- Severe psychosis (current psychotic symptoms and functioning i.e., during the last 6 months based on clinical decision)
- Severe depression and high suicide risk (current episodes i.e., during the last 6 months based on clinical decision)
See the full eligibility criteria
- Adult age (≥ 18 years)
- Opioid dependence according to ICD-10, and ongoing OAT
- 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
- Severe respiratory failure (GOLD 3-4)
- High risk of violent behavior (current violence episodes i.e., during the last 6 months)
- High risk of substance related overdose (current overdoses i.e., during the last 6 months)
- Severe cognitive impairment (IQ<70; assessed if needed based on clinical decision)
- Severe psychosis (current psychotic symptoms and functioning i.e., during the last 6 months based on clinical decision)
- Severe depression and high suicide risk (current episodes i.e., during the last 6 months based on clinical decision)
- Patients who are already being stabilized with prescribed continuous benzodiazepines
- 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)
- Challenges related to ability to understand, consent, or willingness to collaborate in following-up of the study and its protocol
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.