Protocol Number: 05-AA-0121
People 18 years of age and older who are seeking help for drinking-related problems may be eligible for this study.
Participants have a medical, physical, and psychiatric examination, including detailed questions about alcohol and drug use, blood tests, urine tests for illicit drugs and for pregnancy in women who can become pregnant, an electrocardiogram, and a breath alcohol (breathalyzer) test to determine how much alcohol is in the body. Patients who are inebriated may need to be admitted to the hospital for alcohol withdrawal treatment or other medical or mental health problems before continuing with the study. Additional blood tests, imaging studies, or other procedures may be required.
Patients who are alcohol-free for at least 5 days and whose condition is stable have a psychological assessment. They complete several interviews or questionnaires about their thoughts, emotions and personality, past and current physical and mental health, amount and kinds of alcohol and illicit drugs used and their effects, episodes of violence or legal and financial problems, and alcohol use by family members and significant others.
Patients who are alcohol-free for at least 2 weeks and whose condition is stable have magnetic resonance imaging (MRI) and neurocognitive tests (tests of mental capacity). MRI uses a strong magnetic field and radio waves to show structural and chemical changes in the brain. The patient lies on a table enclosed by a metal cylinder (the scanner) for about 30-40 minutes, lying very still for up to 10-15 minutes at a time. Neurocognitive testing involves playing games on the computer that measure the ability to focus attention, retain information briefly in memory, strategize, and plan ahead. Two games involve picking cards from a deck of cards displayed on a computer screen. Another involves paying attention to numbers appearing on a computer screen and clicking a computer mouse when certain numbers appear, or pressing a button in response to different colors on the screen. The fourth game involves choosing between shorter term and longer term gain.
Patients who are alcohol-free for at least 5 days and whose assessments are complete are offered one of two types of outpatient counseling: 1) combined behavioral intervention (CBI), a type of group therapy that teaches coping skills; or 2) medical management (MM), one-on-one counseling with a health care professional designed for people who are also taking medications to help them stop drinking. CBI groups meet once a week for 8 weeks and then once every 2 weeks for 4 weeks; MM consists of 6 sessions, an initial visit and sessions at weeks 1, 2, 4, 8 and 12. Sessions are during outpatient follow-up visits (see below).
During counseling, patients may be able to take an approved medication - naltrexone or acamprosate - or, if a trial is available, an experimental medication to help prevent relapse. While receiving counseling, patients have follow-up clinic visits at weeks 1, 2, 4, 8 and 12. At each visit, patients fill out questionnaires, take a breathalyzer test, have blood drawn, do a urine test for drugs, and, for women, a urine pregnancy test.
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/17/2008