Neurocognitive Functioning Following The PROMETA® Treatment Protocol In Subjects With Alcohol Dependence

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Alcohol Dependence

In brief

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.

Key facts

Study ID

NCT00570388

Run by

Institute of Addiction Medicine

People needed

120

Starts

2007-03-01

Expected to finish

2008-09-01

Last updated by the study team

2008-01-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 benzodiazepines.
• 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 contraception.
• 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

Where it is running

• Institute of Addiction Medicine — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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