Alcoholism Assessment and Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: October 10, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to gather information about people s drinking histories and to evaluate them for other research studies being conducted at the National Institute on Alcohol Abuse and Alcoholism (NIAAA). The evaluation will include a physical examination, blood tests, an MRI scan of the brain and completion of various questionnaires about alcohol use and mood. The information gathered from all of these tests will be used by researchers to gain a better understanding of the disease of alcoholism and determine eligibility for other NIAAA studies. This is an inpatient study so participants will stay at the NIH hospital for at least three weeks and up to six weeks if a person is found to be eligible for other NIAAA research studies.

The study is open to people age 18 and older whose alcohol drinking has caused significant problems in their lives, and who desire alcoholism treatment. Detoxification will be provided if needed, and each person may participate in our alcoholism treatment program. The treatment includes group and individual counseling sessions as well as self-help meetings such as AA. Family counseling and recreational opportunities are also an important part of the treatment experience. The doctors, nurses, social workers and all of our other staff are committed to helping participants design an aftercare program that will help them leave the hospital and remain sober. Participants may also be able to attend a 12-week aftercare program in the NIAAA outpatient clinic.


Condition
Alcoholism
Alcohol Dependence
Alcohol Drinking Related Problems

Study Type: Observational
Official Title: Assessment and Treatment of People With Alcohol Drinking Problems

Resource links provided by NLM:


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

Estimated Enrollment: 2000
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. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
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 with medical problems that cannot be adequately managed at the NIH Clinical Center, as determined by the medically advisory investigator, in consultation with relevant Clinical Center consult services as needed.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Debra Hill (301) 496-1993 debbyh@niaaa.nih.gov
Contact: Nancy DiazGranados, M.D. (301) 496-7515 nancy.diazgranados@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Nancy DiazGranados, M.D. National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00106093     History of Changes
Other Study ID Numbers: 050121, 05-AA-0121
Study First Received: March 19, 2005
Last Updated: October 10, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Alcohol
Alcohol Treatment
DNA
Treatment
Alcohol Dependence
Alcoholism
Alcohol Drinking Related Problems

Additional relevant MeSH terms:
Alcohol Drinking
Alcoholism
Alcohol-Related Disorders
Chemically-Induced Disorders
Drinking Behavior
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on October 23, 2014