None listed
Conditions
Brief summary
Benzodiazepines are a commonly prescribed for anxiety and sleep problems despite their high risk for dependence. Benzodiazepine withdrawal syndrome involves anxiety, tremor, sweating, nausea, headaches, cognitive difficulty, poor memory, muscle pain and potentially seizures and hallucinations. The current first-line treatment for benzodiazepine dependence involves gradual dose reduction so as to avoid sudden onset of withdrawal symptoms however this therapy can take a very long time and the success rate is quite low. Flumazenil, conventionally viewed as a benzodiazepine antagonist with agonist actions having been observed at low doses, has demonstrated potential for treating benzodiazepine withdrawal syndrome. This study aims to assess the efficacy and safety of low-dose flumazenil infusion administered subcutaneously as an option for detoxification from benzodiazepines. It will also explore the role of flumazenil-assisted benzodiazepine withdrawal in maintaining abstinence post-withdrawal.
Interventions
A double-blind, placebo-controlled, cross-over, randomised clinical trial of 2 consecutive 96-hour continuous subcutaneous infusions of flumazenil 16 mg (approx. 167 ug/hr) during a symptom-triggered benzodiazepine taper. The treatment phase of the trial will run for 16 consecutive days, during which participants will be administered oral tablet diazepam 10 mg, as required, based on administration of a withdrawal symptom scale by their carer each time medication is requested. This approach allow
A double-blind, placebo-controlled, cross-over, randomised clinical trial of 2 consecutive 96-hour continuous subcutaneous infusions of flumazenil 16 mg (approx. 167 ug/hr) during a symptom-triggered benzodiazepine taper. The treatment phase of the trial will run for 16 consecutive days, during which participants will be administered oral tablet diazepam 10 mg, as required, based on administration of a withdrawal symptom scale by their carer each time medication is requested. This approach allows for a gradual, symptom-triggered taper from benzodiazepines. A symptom score of 2 or higher on the 6-item CIWA-B scale (McGregor et al., 2003) will indicate the need for a dose of diazepam 10 mg, to a maximum of 1 dose per hour. Participants will receive subcutaneous flumazenil infusion during either the first or second 8-days of treatment, based on a randomized, double-blind, placebo-controlled design. An identical saline placebo infusion will be administered on the alternate 8 days of treatment, with no washout period between. Participants are required to attend a day clinic for assessment by a Dr in order to commence the clinical trial treatment, after which they may return home with a carer or opt to stay as an inpatient, with visits to the clinic on treatment days 1, 4, 8, 9, 12 and 16.
Sponsors
Go Medical Industries Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with daily benzodiazepine use for at least 3 months at a diazepam equivalent dose of 10 mg per day or higher, who want to cease benzodiazepine use.
Exclusion criteria
Patients will be excluded if they suffer epilepsy or have a history of seizures or fitting, are pregnant or are breastfeeding, are co-dependent on alcohol, are under 18 years of age or are unable or unwilling to provide informed consent.
Outcome results
None listed