None listed
Conditions
Brief 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.
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. Duri
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.
Sponsors
Professor Jon Currie
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Both male and female patients admitted to a community-based, residential inpatient treatment unit requesting alcohol withdrawal and ongoing alcohol abstinence maintenance, who have alcohol intake of 6 or more drinks per day over at least the past 3 months.
Exclusion criteria
Inability to take oral medication.pregnancy or breast feeding.known allergy to Bioeffective A, already receiving Bioeffective A, previous treatment for alcohol withdrawal or abstinence maintenance within the past 28 days.
Outcome results
None listed