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

Subcutaneous flumazenil infusion in the management of benzodiazepine dependence

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000513415
Enrollment
20
Registered
2007-10-09
Start date
2007-12-03
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Aim: This project will assess the safety, effectiveness and patient acceptability of administering the medication, flumazenil, to treat benzodiazepine dependence by means of subcutaneous (under the skin) infusion rather than by intravenous infusion. Background: Benzodiazepines are a group of sedative drugs which are commonly prescribed for anxiety and insomnia. Examples include “valium”, “serepax”, and “mogadon”. Dependence on this group of drugs can occur rapidly with regular use, and successful withdrawal and treatment is very difficult. Long-term dependence on benzodiazepines, either prescribed or obtained illicitly through diversion, is therefore recognized as a major public health issue. Current treatment for benzodiazepine dependence usually involves a slow reduction in the benzodiazepine dose over weeks, but is frequently unsuccessful because of the withdrawal symptoms of anxiety and agitation that occur, and so patients remain on benzodiazepines long-term. Flumazenil is a medication that has recently been successfully used to treat benzodiazepine dependence by giving it as an intravenous infusion over several days. Unfortunately, using this method of intravenous infusion is complex and resource intensive, and this limits the availability of this form of treatment for many patients. This project is a pilot study to determine whether giving flumazenil by the simpler subcutaneous route would be an effective alternative that could make treatment available to many more patients.

Interventions

continuous subcutaneous flumazenil infusion at rate of 4mg/24 hours for 4 days, followed by 24 hours observation after ceasing infusion

Sponsors

St Vincent's, Melbourne
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to -2147483648 No limit
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026