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AlcoholismNCT00106093

Alcoholism Assessment and Treatment

An observational study of Alcoholism and Alcohol Dependence, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
How many people
1,192 participants
Where
1 siteUnited States
Study dates
16 Mar 2005to 8 Sep 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age greater than 18 years old.
  • Are seeking help for alcohol drinking-related problems.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

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.

Read the 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 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.

Keywords
Alcohol, Alcohol Treatment, DNA, Treatment, Alcohol Dependence, Alcoholism, Alcohol Drinking Related Problems
Medical subject headings
Alcoholism

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2005 (estimated)
  2. Study start16 Mar 2005
  3. Study completion8 Sep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
1,192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00106093
Sponsor's protocol ID
050121
Other IDs
05-AA-0121
Status last verified
8 Sep 2015
First submitted
19 Mar 2005
Last updated
27 Jun 2018
Results posted
No

Publications

  • O'Connor PG, Schottenfeld RS. Patients with alcohol problems. N Engl J Med. 1998 Feb 26;338(9):592-602. doi: 10.1056/NEJM199802263380907. No abstract available.

    PubMed 9475768
  • COMBINE Study Research Group. Testing combined pharmacotherapies and behavioral interventions in alcohol dependence: rationale and methods. Alcohol Clin Exp Res. 2003 Jul;27(7):1107-22. doi: 10.1097/00000374-200307000-00011.

    PubMed 12878917
  • O'Brien CP. Treatment of alcoholism as a chronic disorder. Alcohol. 1994 Nov-Dec;11(6):433-7. doi: 10.1016/0741-8329(94)90063-9.

    PubMed 7865139
  • Wallen GR, Brooks AT, Whiting B, Clark R, Krumlauf MC, Yang L, Schwandt ML, George DT, Ramchandani VA. The prevalence of sleep disturbance in alcoholics admitted for treatment: a target for chronic disease management. Fam Community Health. 2014 Oct-Dec;37(4):288-97. doi: 10.1097/FCH.0000000000000040.

    PubMed 25167069

Questions about this trial

What is this clinical trial studying?

An observational study of Alcoholism and Alcohol Dependence, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00106093, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2018.

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