Alcoholism Clinical Trial
Official title:
Assessment and Treatment of People With Alcohol Drinking Problems
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.
OBJECTIVE: 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.
STUDY POPULATION: 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.
DESIGN: Participants 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 changes 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.
OUTCOME MEASURES: Because of the evidence-based nature of all assessments used in this
protocol, data obtained through them can serve at least three clinical purposes: first, to
provide a basis for individualizing patient treatment, enhancing motivation to change, and
following-up such treatment for the sole purpose of providing optimal clinical care; second,
to provide patient characteristics and outcome data for specific research protocols to which
the patient may additionally and separately consent; and third, to provide data for
monitoring the performance and functioning of the program as a whole.
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