A pilot study of subcutaneous flumazenil infusion in the management of benzodiazepine dependence

Phase 1

• Conditions: benzodiazepine dependence; Mental Health - Addiction

• Registration Number: ACTRN12607000513415
• Lead Sponsor: St Vincent's, Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

benzodiazepine dependent (daily use of benzodiazepine > 3 months at diazepam equivalent of 10mg or greater, with withdrawal symptoms on attempted cessation); wishing to withdraw from, and cease using benzodiazepines; 18 years or older; not pregnant or breastfeeding

Exclusion Criteria

under 18 years; pregnant or breastfeeding; unable or unwilling to give informed consent; medical condition that precludes cessation of benzodiazepine medication

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
percentage of patients entering treatment who complete benzodiazepine withdrawal and cease using benzodiazepines[day 5 after commencing flumazenil infusion]

Secondary Outcome Measures

Name	Time	Method
quantitative severity of benzodiazepine withdrawal as measured by Clinical Institute Withdrawal Assessment for Benzodiazepines (CIWA-B) withdrawal scale[daily for 5 days during treatment];percentage of patients entering treatment who develop local tissue reaction to infusion[daily for 5 days during treatment]