NIH Clinical Research Studies

Protocol Number: 05-AA-0121

Active Accrual, Protocols Recruiting New Patients

Assessment and Treatment of People with Alcohol Drinking Problems
This study will provide evaluation and treatment of a broad range of people with drinking problems. The program consists of a state-of-the-art clinical work-up and uses outpatient counseling treatment approaches.

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.

Sponsoring Institute:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:

Age greater than 18 years old.

Are seeking help for alcohol drinking-related problems.


People who present with complicated medical problems requiring intensive medical or diagnostic management, such as:

Hypertensive emergency;

Serious GI bleeding;

Major organ or body system dysfunction such as decompensated liver disease, renal failure, myocardial ischemia, congestive heart failure or cerebrovascular disease, major endocrine problems such as uncontrolled diabetes, pancreatic or thyroid disease.

People who are infected with the Human Immunodeficiency Virus (HIV).

Serious neuro-psychiatric conditions which impair judgment or cognitive function to an extent that precludes them from providing informed consent, such as acute psychosis or severe dementia (incompetent individuals).

People who are unlikely or unable to complete the treatment program because they become or are likely to be incarcerated while on the protocol.

People who are required to receive treatment by a court of law or who are involuntarily committed to treatment.

Special Instructions:
Currently Not Provided
Addiction Severity Index
Combined Behavioral Intervention
Medical Management
Recruitment Keyword(s):
Alcohol Dependence
Alcohol drinking related problems
Alcohol Dependence
Alcohol drinking related problems
Investigational Drug(s):
Investigational Device(s):
Supporting Site:
National Institute on Alcohol Abuse and Alcoholism

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793


O'Connor PG, Schottenfeld RS. Patients with alcohol problems. N Engl J Med. 1998 Feb 26;338(9):592-602. Review. No abstract available.

COMBINE Study Research Group. Testing combined pharmacotherapies and behavioral interventions in alcohol dependence: rationale and methods. Alcohol Clin Exp Res. 2003 Jul;27(7):1107-22.

O'Brien CP. Treatment of alcoholism as a chronic disorder. Alcohol. 1994 Nov-Dec;11(6):433-7. Review.

Active Accrual, Protocols Recruiting New Patients

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