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Alcoholism Assessment and Treatment
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), December 2008
Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00106093
  Purpose

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 inte...


Condition
Alcoholism
Alcohol Dependence
Alcohol Drinking Related Problems

MedlinePlus related topics: Alcohol Consumption Alcoholism Mental Health
Drug Information available for: Ethanol
U.S. FDA Resources
Study Type: Observational
Official Title: Assessment and Treatment of People With Alcohol Drinking Problems

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1000
Study Start Date: March 2005
Detailed Description:

The purpose of this protocol is to create a mechanism whereby the intramural program of the NIAAA can evaluate and treat a broad range of people with drinking problems at the NIH Clinical Center (CC) in Bethesda, MD. Through this program, participants will receive comprehensive, state-of-the-art treatment for their alcohol, psychosocial and medical problems and the program will be able to evaluate and recruit participants for other, more focused clinical research efforts to advance its research goals. Additionally, this will allow investigators and staff to gain broad training experience in alcohol and addiction medicine through the clinical care of such patients. The protocol is open to any adult who is seeking help for a drinking problem and who is likely to qualify to participate in another NIAAA protocol. Participants will be recruited through local media and professional avenues in the Washington, DC Metro area. They will be evaluated by a nurse and physician, among others, who will determine the need for hospitalization, detoxification and to address other issues. For those needing medically supervised detoxification, a standard program of monitoring and treatment with benzodiazepines and other medications will be instituted. A standard battery of screening blood, urine and other clinically indicated tests, an electrocardiogram, chest x-ray and MRI of the brain will be done as part of the comprehensive medical and neurological assessment. Following at least five days of abstinence from alcohol, participants will undergo a series of verbal and observational-type assessments designed to evaluate psychiatric co-morbidity, psychopathology, psychosocial problems, neurocognitive function, personality and other factors relevant to alcoholism treatment. Participants will then be offered a 12-16 week course of outpatient treatment, consisting of either of two, manual-based therapies used in Project COMBINE, a large, NIAAA-sponsored national trial of counseling and medication therapies for alcohol dependence. The first is an intensive counseling approach (12 sessions) called Combined Behavioral Intervention (CBI) and the second, Medical Management (MM), is a series of brief counseling sessions every 2-4 weeks. At five points during the outpatient phase participants will come to the clinic for selected blood and urine tests, interviews and verbal/observational assessments to evaluate abstinence from alcohol and identify change in various psychological dimensions. During their participation in this protocol, participants will be approached to consider enrolling in other clinical research protocols such as imaging studies and drug-treatment trials. For participants willing to participate in these other protocols, other appropriate consent(s) will be obtained.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Age greater than 18 years old.

Are seeking help for alcohol drinking-related problems.

EXCLUSION CRITERIA:

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00106093

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Colorado
University of Colorado Recruiting
Denver, Colorado, United States, 80220-3706
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23284
Sponsors and Collaborators
  More Information

NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: 050121, 05-AA-0121
Study First Received: March 19, 2005
Last Updated: January 15, 2009
ClinicalTrials.gov Identifier: NCT00106093  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Dependence
CIWA
Addiction Severity Index
CPRS-S-A
Combined Behavioral Intervention
Medical Management
Alcohol Dependence
Alcoholism
Alcohol drinking related problems

Study placed in the following topic categories:
Behavior, Addictive
Mental Disorders
Alcoholism
Substance-Related Disorders
Drinking Behavior
Disorders of Environmental Origin
Alcohol-Related Disorders
Alcohol Drinking
Ethanol

ClinicalTrials.gov processed this record on January 16, 2009