Alcoholism Assessment and Treatment

This study is currently recruiting participants.
Verified August 2012 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00106093
First received: March 19, 2005
Last updated: September 1, 2012
Last verified: August 2012

March 19, 2005
September 1, 2012
March 2005
 
 
 
Complete list of historical versions of study NCT00106093 on ClinicalTrials.gov Archive Site
 
 
 
 
 
Alcoholism Assessment and Treatment
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.

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. The protocol will allow us to evaluate and recruit participants who will then be eligible for more focused clinical research efforts to advance the NIAAA research goals. Additionally, this protocol 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 admission, 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. Following discharge from the inpatient program, participants will be offered up to 16 weeks standard of care behavioral outpatient treatment. 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.

Observational
 
 
 
 
  • Alcoholism
  • Alcohol Dependence
  • Alcohol Drinking Related Problems
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
 
 
  • 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.

Both
18 Years to 65 Years
No
Contact: Debra Hill (301) 402-2721 debbyh@mail.nih.gov
Contact: David T George, M.D. (301) 435-9385 tedg@mail.nih.gov
United States
 
NCT00106093
050121, 05-AA-0121
 
 
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 
Principal Investigator: David T George, M.D. National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institutes of Health Clinical Center (CC)
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP