This study will test the safety and efficacy of the PROMETA® Treatment Protocol (which
includes the benzodiazepine antagonist flumazenil) in reversing the neurocognitive
impairment and this in turn will lead to improved ability to resist alcohol related cues and
enhance involvement in psychosocial treatment.
The principal aim of this study is to extend our evaluation of the PROMETA® Treatment
Protocol as a means to improve neurocognitive functioning in recently detoxified alcohol
dependent subjects. For many alcohol dependent patients entering treatment, a range of
neurocognitive deficits are present that not only had adverse effects on the patient's
ability to function and think clearly but these deficits also impair the process of
addiction treatment. For example, alcohol dependent subjects typically experience high
levels of alcohol craving in the early stages of treatment. The patient is left with the
choice of relieving craving by drinking alcohol to provide immediate relief of craving
symptoms or abstaining from alcohol to obtain long-term benefits from recovery of the
complications from excessive drinking. We have previously shown in open label trials that
the PROMETA® Treatment Protocol helps stimulant abusers in the early stages of recovery,
have relatively low rates of relapse to stimulant use. It is not clear if the Protocol is
effective because of less urges to use stimulants or the ability to resist these urges is
improved from a recovery of Neurocognitive functioning. The present proposal extends our
previous research by comparing the efficacy of the PROMETA® Treatment Protocol in a double
blind placebo controlled trial using a new population of substance abusers (alcohol
dependent subjects) and assessing the effects of the PROMETA® Treatment Protocol on
neurocognitive functioning, particularly those aspects of functioning that affect the
ability to make decisions that have important long-term benefits.
- Patient must meet DSM-IV criteria for current diagnosis of alcohol dependence.
- In the past 30 days, patient had an average of >15 standard alcohol drinks/week with
at least one day of five or more drinks.
- Patient must have successfully completed detoxification from alcohol (abstinent for
three consecutive days). As evidenced by self-report or three negative breathalyzer
reading and a CIWA-Ar score less than 6.
- Patient understands and signs the consent.
- Patients with a current DSM-IV diagnosis of any substance dependence other than
alcohol, nicotine, or cannabis.
- Patients with a current or past history of DSM-IV diagnosis of Panic Disorder
- Evidence of benzodiazepine use in the past 15 days, determined by self-report and/or
by a urine drug screen
- Patients with a seizure disorder being managed with a benzodiazepine or for whom a
benzodiazepine is being considered
- Patients who are currently being treated with psychotropic medications, including
disulfiram, naltrexone, or acamprosate at the time of study entry.
- Patients with a history of unstable or serious medical illness, including need for
- Known severe physical or medical illnesses such as AIDS, active hepatitis,
- Current severe psychiatric symptoms, e.g., psychosis, dementia, acute suicidal or
homicidal ideation, mania or depression requiring newly initiated antidepressant or
psychotropic therapy, or which would make it unsafe for the patient to participate in
the opinion of the primary investigator.
- Patients who have used investigational medication in the past 30 days.
- Female patients who are pregnant, nursing, or not using a reliable method of
- Patients with a condition that would make intravenous administration of medications
difficult (e.g. absence of suitable peripheral veins).
- Have a known or hypersensitivity to medication components of PROMETA®TM
- Have been treated with PROMETA® for any reason currently or in the past year