NCT00106093

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,192

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2005

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2005

Completed
10.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2015

Completed
Last Updated

June 27, 2018

Status Verified

September 8, 2015

First QC Date

March 19, 2005

Last Update Submit

June 26, 2018

Conditions

AlcoholismAlcohol DependenceAlcohol Drinking Related Problems

Keywords

AlcoholAlcohol TreatmentDNATreatmentAlcohol DependenceAlcoholismAlcohol Drinking Related Problems

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

  • 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.

    PMID: 9475768BACKGROUND

  • 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.

    PMID: 12878917BACKGROUND

  • 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.

    PMID: 7865139BACKGROUND

  • 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.

    PMID: 25167069DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Nancy DiazGranados, M.D.

    National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2005

First Posted

March 21, 2005

Study Start

March 16, 2005

Study Completion

September 8, 2015

Last Updated

June 27, 2018

Record last verified: 2015-09-08

Locations

US(1)