Not Yet RecruitingPhase 2Phase 3ACTRN12609000649213

A placebo-controlled, randomized clinical trial of Bioeffective A in the management of acute alcohol withdrawal and alcohol abstinence maintenance

A placebo-controlled, randomized clinical trial of Bioeffective A in the management of acute alcohol withdrawal and alcohol abstinence maintenance in alcohol dependent patients admitted to a community-based residential withdrawal unit.

Sponsor

Professor Jon Currie

Enrollment

56 participants

Start Date

Oct 12, 2009

Study Type

Interventional

Conditions

alcohol withdrawal

Summary

The purpose of this project is to assess a new treatment for both alcohol withdrawal and alcohol abstinence maintenance in alcohol dependent patients who are admitted to hospital and wish to cease using alcohol. Alcohol withdrawal can be a severe condition. Usually it is treated with benzodiazepines such as diazepam, but these medications can have dangerous side-effects such as excessive sedation and depression of respiration. The new treatment uses a complementary medical supplement called Bioeffective A. Bioeffective A has antioxidant properties and may help to reduce the severity of alcohol withdrawal symptoms and shorten the duration of alcohol withdrawal without causing sedation or depressing respiration, and may also help to prevent relapse back to alcohol use once abstinence has been established.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether a supplement called Bioeffective A can help people safely manage alcohol withdrawal symptoms and maintain sobriety. It is for adults aged 18 and over who are admitted to a residential treatment unit for alcohol withdrawal and have been drinking 6 or more drinks per day for at least 3 months. People who are pregnant, have allergies to the supplement, or were recently treated for alcohol withdrawal are not eligible.

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

Patients entered into the trial will be randomized to receive either Bioeffective A 320mg three times daily (1 capsule three times daily) or placebo 1 capsule three times daily for the full 12 weeks duration of the trial. The trial will examine the effect of Bioeffective A versus placebo during two phases of treatment; Phase 1: acute alcohol withdrawal (defined as the first 7 days following cessation of alcohol intake), and Phase 2: the subsequent 11 weeks of alcohol abstinence maintenance. During Phase 1 (acute alcohol withdrawal) the trial will examine the effect of Bioeffective A versus placebo on the outcome of conventional treatment of alcohol withdrawal in which all subjects will receive benzodiazepines prescribed as needed according to the severity of alcohol withdrawal as measured by the Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) alcohol withdrawal scale. Phase 2 of the trial will examine the effect of Bioeffective A versus placebo on the outcome of conventional treatment of alcohol abstinence maintenance, during which all subjects will receive supportive counselling during attendance at a regular schedule of outpatient clinic reviews.