None listed
Conditions
Brief summary
Alcohol detoxification is associated with a myriad of withdrawal symptoms ranging from headaches and nausea to anxiety and potential seizures. Typically relief for these withdrawal symptoms involves treatment with benzodiazepines, which come with their own set of associated risks. Benzodiazepines have a high potential for dependence as well as cognitive and psychomotor impairment. Flumazenil, conventionally viewed as a benzodiazepine antagonist with agonist actions having been observed at low doses, has demonstrated potential as a management tool to assist both alcohol and benzodiazepine withdrawal. This study aims to assess the efficacy and safety of low-dose flumazenil infusion administered subcutaneously as an option for detoxification from alcohol. It will also explore the role of flumazenil-assisted alcohol withdrawal in maintaining abstinence post-withdrawal.
Interventions
A double-blind placebo-controlled randomised clinical trial of a 96-hour continuous subcutaneous infusion of flumazenil 16 mg (approx. 167mcg/hr) for the treatment of alcohol withdrawal syndrome.
Arm 1: 96-hour continuous subcutaneous infusion of flumazenil 16 mg (approx. 167mcg/hr) plus oral diazepam 10-20 mg hourly as required. The requirement for diazepam will be determined by patient carers using the CIWA-Ar scale as follows; no diazepam to be given for a score less than or equal to 7, diaz
A double-blind placebo-controlled randomised clinical trial of a 96-hour continuous subcutaneous infusion of flumazenil 16 mg (approx. 167mcg/hr) for the treatment of alcohol withdrawal syndrome. Arm 1: 96-hour continuous subcutaneous infusion of flumazenil 16 mg (approx. 167mcg/hr) plus oral diazepam 10-20 mg hourly as required. The requirement for diazepam will be determined by patient carers using the CIWA-Ar scale as follows; no diazepam to be given for a score less than or equal to 7, diazepam 10 mg for a score between 8 and 14 inclusive and diazepam 20 mg for a score of 15 or higher.
Sponsors
Go Medical Industries Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
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
Participants will be patients of Fresh Start Recovery Programme who are receiving naltrexone implant treatment for problematic alcohol use. To be included in the study, patients must score 22 or higher on the Alcohol Dependence Scale (Skinner & Allen, 1982) and have the desire to cease alcohol consumption.
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 benzodiazepines, are under 18 years of age or are unable or unwilling to provide informed consent.
Outcome results
None listed