Prometa Protocol for Alcohol Dependence

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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 medications (plus ancillary non-placebo controlled medications) and their placebos (inactive drugs) will be utilized to treat both alcohol withdrawal, promote abstinence, and reduce drinking over approximately a six-week treatment period. All participants will meet criteria for Alcohol Dependence and be drinking heavily up until 72 hours prior to receiving the first study drug. They will be injected one drug (flumazenil or placebo) over a two day period and receive the second one (gabapentin or placebo) by mouth for 39 days. The main hypothesis is that this protocol will reduce early alcohol withdrawal symptoms and will reduce relapse to drinking and promote abstinence compared to the placebo (inactive) drug group. Secondary outcomes that will be evaluated include reduction in craving, improvement in sleep, brain activity and mood.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Ethanol; Flumazenil; Gabapentin; gamma-Aminobutyric Acid

Criteria

Inclusion Criteria:

1. Age 18 - 70.

2. 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.

3. No more than 72 hours since last drink of alcohol. Rationale: to focus on symptoms occurring during the early alcohol cessation period.

4. 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.

5. Able to read and understand questionnaires and informed consent.

6. Has stable housing for past 3 months.

Exclusion Criteria:

1. Currently meets DSM-IV criteria for any other psychoactive substance dependence disorder except nicotine dependence.

2. Any psychoactive substance abuse, except marijuana and nicotine, within the last 30 days as evidenced by subject report or urine drug screen.

3. 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.

4. No use of benzodiazepines in excess of three times in the past two weeks by self report and urine drug screen.

5. Subjects must not be taking zolpidem (Ambien™), zaleplon (Sonata™), or eszopiclone (Lunesta™) in excess of three times in past two weeks.

6. No history of delirium tremens or alcohol withdrawal seizures.

7. Has current suicidal ideation with plan or homicidal ideation.

8. Need for maintenance or acute treatment with any psychoactive medication including antiseizure medications.

9. Use of disulfiram, naltrexone, acamprosate, or anticonvulsants in last 30 days.

10. Clinically significant medical problems such as cardiovascular, renal, GI, or endocrine problem that would impair participation or limit medication ingestion.

11. 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.

12. Has current charges pending for a violent crime (not including DUI related offenses).

13. Has taken gabapentin or flumazenil in the last month or has experienced adverse effects from it at any time in the past.

14. Hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) greater than 3 times normal at screening.

15. Persons with metal implants or pacemaker since fMRI will be used.