Medication Development for Protracted Abstinence in Alcoholism: Naltrexone Versus Acamprosate

Trial ID:
HSC-07-4871
Barbara Mason
The purpose of this study is to develop and validate a human laboratory model for prediction of medication efficacy in clinical trials for relapse prevention in alcohol dependence. This study involves two laboratory sessions and an fMRI scan.

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

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