Status:
COMPLETED
Prometa Protocol for Alcohol Dependence
Lead Sponsor:
Medical University of South Carolina
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
This is a placebo controlled trial (some people receive active and some people receive inactive medication) to evaluate the effectiveness of a new protocol to treat alcohol dependence. Two main medica...
Detailed Description
Approximately 60 alcohol dependent individuals who are drinking heavily up until 72 hours, or less, prior to study participation will be randomized to receive either flumazenil (intravenously)on two s...
Eligibility Criteria
Inclusion
- Age 18 - 70.
- Participants will meet criteria for primary DSM IV alcohol dependence, drink on at least 70% of days in the last 30 days prior to assessment, and drink at least 5 drinks per drinking day.
- No more than 72 hours since last drink of alcohol. Rationale: to focus on symptoms occurring during the early alcohol cessation period.
- Low CIWA-Ar group: have a CIWA-Ar score less than or equal to 6; High CIWA-Ar group: have a CIWA-Ar score greater than or equal to 7 but less than or equal to 15.
- Able to read and understand questionnaires and informed consent.
- Has stable housing for past 3 months.
Exclusion
- Currently meets DSM-IV criteria for any other psychoactive substance dependence disorder except nicotine dependence.
- Any psychoactive substance abuse, except marijuana and nicotine, within the last 30 days as evidenced by subject report or urine drug screen.
- Meets DSM-IV criteria for current axis I disorders of major depression, panic disorder, obsessive-compulsive disorder, generalized anxiety disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder. The rationale for excluding them is that symptoms from these disorders may affect dependent variables and complicate interpretation of the data.
- No use of benzodiazepines in excess of three times in the past two weeks by self report and urine drug screen.
- Subjects must not be taking zolpidem (Ambien™), zaleplon (Sonata™), or eszopiclone (Lunesta™) in excess of three times in past two weeks.
- No history of delirium tremens or alcohol withdrawal seizures.
- Has current suicidal ideation with plan or homicidal ideation.
- Need for maintenance or acute treatment with any psychoactive medication including antiseizure medications.
- Use of disulfiram, naltrexone, acamprosate, or anticonvulsants in last 30 days.
- Clinically significant medical problems such as cardiovascular, renal, GI, or endocrine problem that would impair participation or limit medication ingestion.
- Sexually active females of child-bearing potential who are pregnant (by -beta HCG), nursing, or who are not using a reliable form of birth control.
- Has current charges pending for a violent crime (not including DUI related offenses).
- Has taken gabapentin or flumazenil in the last month or has experienced adverse effects from it at any time in the past.
- Hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) greater than 3 times normal at screening.
- Persons with metal implants or pacemaker since fMRI will be used.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00262639
Start Date
December 1 2005
End Date
March 1 2008
Last Update
February 15 2019
Active Locations (1)
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1
MUSC-Center for Drug and Alcohol Programs
Charleston, South Carolina, United States, 29425