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

Phase 1

• Conditions: Benzodiazepine dependence; Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]

• Registration Number: EUCTR2021-004981-37-NO
• Lead Sponsor: Helse Bergen HF

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-11
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

Inclusion 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Severe respiratory failure (GOLD 3-4)
•High risk of violent behavior (current violence episodes)
•High risk of substance related overdose (current overdoses)
•Severe cognitive impairment (IQ<70)
•Severe psychosis (current psychotic symptoms and functioning)
•Severe depression and high suicide risk (current episodes)
•Patients who are already being prescribed continuous benzodiazepines
•Pregnancy and breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified