Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106093
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
2005-03-19
Brief Title:
Alcoholism Assessment and Treatment
Sponsor:
National Institute on Alcohol Abuse and Alcoholism NIAAA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Assessment and Treatment of People With Alcohol Drinking Problems
Status:
COMPLETED
Status Verified Date:
2015-09-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 verbalobservational 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 consents 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
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 verbalobservational 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 consents 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-AA-0121 | None | None | None |