None listed
Conditions
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
Sponsors
Study design
Eligibility
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