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 Interventions (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, interview 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.

Further Study Details: 

Expected Total Enrollment:  2000

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.

Genders Eligible for Study:  Both

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.

Maryland
      National Institute on Alcohol Abuse and Alcoholism (NIAAA), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting

Study ID Numbers:  050121; 05-AA-0121
Record last reviewed:  March 8, 2005
Last Updated:  March 29, 2005
Record first received:  March 19, 2005
ClinicalTrials.gov Identifier:  NCT00106093
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08