Medication Development for Protracted Abstinence in Alcoholism: Naltrexone Versus Acamprosate
- Trial ID:
- HSC-07-4871
- Barbara Mason
Inclusion Criteria:
- Males or females ≥ 18 and ≤ 55 years of age
- Meets DSM-IV criteria for current alcohol dependence
- Does not desire treatment
- Alcohol free, as verified by breath alcohol concentration, with a CIWA ≤ 8, at the time of testing, with no evidence of drinking for at least 3 days but no more than 7 days prior to the cue reactivity session
- Able to complete and understand questionnaires and study procedures in English
- Verbal I.Q. estimate ≥ 85
- Signed informed consent
Exclusion Criteria:
- Currently meets DSM-IV criteria for dependence on substances other than alcohol or nicotine
- Significant medical disorders that will increase potential risk or interfere with study participation
- Sexually active women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control
- Meets DSM-IV criteria for a major Axis I disorder, including depression or anxiety disorders
- Treatment within the month prior to screening with investigational medications or those which may influence drinking outcome, e.g., disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral), antidepressants or other psychotropic agents
- Chronic treatment with any narcotic-containing medications during the previous month or evidence of current opiate use
- Liver function tests more than three times normal or elevated bilirubin
- No fixed domicile and/or no availability by telephone or beeper
- Current involvement in or plans for treatment prior to study completion
- Patients who have a history of adverse drug reactions to the study drugs or their ingredients
- Failure to take double-blind medication as prescribed
- Claustrophobic (MRI is small environment)
- Non removable metal, e.g., braces (metals are dangerous for MRI)
- Is in need of or currently taking psychoactive medication (could alter cerebral blood flow characteristics)
- Inability to understand or comply with the provisions of the protocol or consent form
- History of neurological disorder, e.g., seizures, meningitis, migraine, HIV, head trauma with loss of consciousness > 2 minutes, or learning disability
- Left-handed (lateralization interpretations on fMRI are complicated with left-handed subjects
Why isn't this trial accepting new patients?
The trial may have a limited enrollment number, reached its maximum, or come to the end of its enrollment period. View trials that are recruiting
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