NCT00001673

Brief Summary

This protocol has three purposes: (1) to evaluate subjects for inclusion or exclusion from other NIAAA protocols; (2) to provide a common set of descriptive information that will be available on all NIAAA research subjects; (3) to allow NIAAA medical and nursing staff to treat alcoholic patients for acute alcohol intoxication or alcohol withdrawal before requiring patients to consent to evaluation for participation in research studies. Information collected will include such items as psychiatric diagnoses, presence or absence of brain, liver or other organ damage, history of the amount of past alcohol consumption, other substance use and family history of alcoholism. This information will allow investigators to determine for which, if any, NIAAA research studies a subject is eligible. In order to avoid requiring intoxicated subjects to consent for procedures such as HIV testing, psychiatric interviews, and Magnetic Resonance Imaging (MRI) of the brain we will obtain consent from all alcoholic subjects in two phases, using two separate consent forms. The first consent form will express the subject's desire to be admitted to the NIAAA inpatient unit for the purpose of treatment for alcoholism and will authorize only medical evaluation and treatment for alcoholism and associated problems. After an alcoholic subject has been admitted to the inpatient unit and is judged to be no longer intoxicated or suffering from acute alcohol withdrawal he or she will be presented with the second consent which will describe the evaluation for participation in other NIAAA research studies. Non-alcoholic, healthy controls will sign only one consent form describing the data to be collected and evaluation for participation in other NIAAA research studies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 1997

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

October 2, 1997

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
6.5 years until next milestone

First Posted

Study publicly available on registry

April 20, 2006

Completed
9.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2015

Completed
Last Updated

October 6, 2017

Status Verified

December 15, 2015

First QC Date

November 3, 1999

Last Update Submit

October 5, 2017

Conditions

Keywords

AlcoholicsScreeningHealthy VolunteersViolent AbusersIllicit Drug TestingBlood TestsNormal Volunteer

Eligibility Criteria

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

You may qualify if:

  • In good health.
  • Over 18 years of age.
  • Not seeking treatment for alcohol or other drug use.

You may not qualify if:

  • \) Serious medical conditions that require ongoing 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 (3)

  • Koob GF, Nestler EJ. The neurobiology of drug addiction. J Neuropsychiatry Clin Neurosci. 1997 Summer;9(3):482-97. doi: 10.1176/jnp.9.3.482.

    PMID: 9276849BACKGROUND
  • Heinz A, Mann K, Weinberger DR, Goldman D. Serotonergic dysfunction, negative mood states, and response to alcohol. Alcohol Clin Exp Res. 2001 Apr;25(4):487-95.

    PMID: 11329486BACKGROUND
  • Heinz A, Ragan P, Jones DW, Hommer D, Williams W, Knable MB, Gorey JG, Doty L, Geyer C, Lee KS, Coppola R, Weinberger DR, Linnoila M. Reduced central serotonin transporters in alcoholism. Am J Psychiatry. 1998 Nov;155(11):1544-9. doi: 10.1176/ajp.155.11.1544.

    PMID: 9812115BACKGROUND

MeSH Terms

Conditions

Alcoholic IntoxicationAlcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Reza Momenan, Ph.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

November 3, 1999

First Posted

April 20, 2006

Study Start

October 2, 1997

Study Completion

December 15, 2015

Last Updated

October 6, 2017

Record last verified: 2015-12-15

Locations