RecruitingPhase 2Phase 3ACTRN12617000039381

The role of flumazenil infusion in the treatment of alcohol withdrawal

Sponsor

Go Medical Industries Pty Ltd

Enrollment

45 participants

Start Date

Feb 24, 2016

Study Type

Interventional

Conditions

Alcohol withdrawal syndrome

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a low-dose medication called flumazenil, given through a small pump under the skin, can help people safely withdraw from alcohol dependence with fewer withdrawal symptoms. Alcohol withdrawal can be dangerous and usually requires medications that themselves carry risks. Flumazenil may offer a safer option to manage this process. You may be eligible if: - You are 18 years old or older - You are a patient at the Fresh Start Recovery Programme - You are receiving naltrexone implant treatment for problematic alcohol use - You have a high score on the Alcohol Dependence Scale (22 or higher) - You want to stop drinking alcohol You may NOT be eligible if: - You have epilepsy or a history of seizures - You are pregnant or breastfeeding - You are also dependent on benzodiazepine medications (like Valium or Xanax) - You are under 18 years old - You are unable or unwilling to give informed consent Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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. Ar

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.

Locations(1)

WA, Australia

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ACTRN12617000039381

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