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Protocol Details

Unit and Clinic Evaluation, Screening, Assessment, and Management

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

14-AA-0181

Sponsoring Institute

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: NA

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Phenotypes;
Alcohol Use;
Alcohol;
Alcohol Dependence;
Genetics

Recruitment Keyword(s)

None

Condition(s)

Alcoholism

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute on Alcohol Abuse and Alcoholism

Background:

- About 17 million adults had an alcohol use disorder in 2012. Researchers want to follow people that have alcohol problems and want treatment, as well as those who do not want treatment and healthy volunteers. They also want to gather information on people with and without alcohol problems, including information on genes and biological processes in the body.. This will help them better understand, prevent, and treat alcohol problems.

Objective:

-To look at a broad range of traits in people who are healthy people and people with alcohol problems. To study them for potential eligibility for other research protocols conducted at the NIH Clinical Center.

Eligibility:

- Adults age 18 and older.

- Not being pregnant or imprisoned.

Design:

- Participants will have a physical exam. They will answer questions about their health and alcohol and drug use. They will have an electrocardiogram to check their heart. They will have blood, urine, and breath alcohol tests.

- Participants without alcohol problems, or who have them but do not want treatment, can sign the second consent for screening and research.

- Participants that have alcohol problems and want treatment will be treated at the NIH Clinical Center. They will be offered to sign the second consent at a later time.

- Participants may join an inpatient treatment and detox program. It could last up to 6 weeks. Or they may join an outpatient program. Some may do both.

- After discharge, participants may be called and asked questions about their drinking and health.

- If participants sign the second consent, they:

- will complete paper- and computer-based questionnaires.

- will give blood samples.

- may have a brain scan using magnetic resonance imaging. They will lie on a table that slides in and out of a cylinder that takes pictures. The machine makes loud noises. They will get earplugs.

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Eligibility

INCLUSION CRITERIA:

Any individual with greater than or equal to 18 years of age who expressed interest in participating in this study and/or other research studies offered at NIAAA during the brief telephone pre-screening may be enrolled. Age is verified at the NIH Clinical Center (CC) Admissions team at the time the patient signs the NIH Clinical Center General Admission Consent. This is standard operating procedure at the NIH CC for both outpatient and inpatient participants.

EXCLUSION CRITERIA:

Given that this is a screening protocol, there are no exclusion criteria per se that apply after a participant signs the Clinical Management consent. In fact, we will evaluate participants (including medical and psychiatric evaluations) only after the first-step Clinical Management Consent form is signed. However, potential participants are pre-screened on the phone and, based on the information provided on the phone, the following categories are excluded because they are not suitable study participants:

-Women who are pregnant

-Individuals < 18 years of age

-Prisoners

-Exclusionary for ANA substudy: positive breath alcohol test (BrAC) on the day(s) of testing

It is important to keep in mind that after participants sign the consent, new information may be made available during the study that can lead the Investigators to withdraw a participant. For example, a participant may have a positive pregnancy test (i.e., she was not aware or did not report during the telephone pre-screening). In this case, the participant will be referred to appropriate care that can best manage and follow-up with their specific clinical needs. However, detoxification and treatment at NIH under the clinical management consent will still be offered to participants that could benefit from our treatment program. In the case of a pregnant participant no research procedures will be done. Only the clinical management will

be offered to pregnant participantsAnother scenario may be that a participant may be arrested during their participation in the study based on new found information obtained by proper authorities (including NIH Police); in this case, a member of the NIH Clinical Center Social Worker Department will be notified.

Finally, at the time of the consent process, those participants who are unable to complete all of the questions in the NIDA/NIAAA Evaluation of Potential Research Participants Ability to Consent will not be enrolled (i.e., they will not sign the consent form) and will be referred for appropriate care.


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Citations:

Svanborg P, Asberg M. A new self-rating scale for depression and anxiety states based on the Comprehensive Psychopathological Rating Scale. Acta Psychiatr Scand. 1994 Jan;89(1):21-8.

Mattila-Evenden M, Svanborg P, Gustavsson P, Asberg M. Determinants of<TAB>self-rating and expert rating concordance in psychiatric out-patients, using the affective subscales of the CPRS. Acta Psychiatr Scand. 1996 Dec;94(6):386-96.

Koenig LB, Jacob T, Haber JR. Validity of the lifetime drinking history: a<TAB>comparison of retrospective and prospective quantity-frequency measures. J Stud<TAB>Alcohol Drugs. 2009 Mar;70(2):296-303.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Nancy Diazgranados, M.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
BG 10-CRC RM 1-5330
10 CENTER DR
BETHESDA MD 20814
(301) 435-9386
nancy.diazgranados@nih.gov

Megan S. Carraco
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
BG 10-CRC RM 1-3471
10 CENTER DR
BETHESDA MD 20814
(301) 496-5055
megan.carraco@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02231840

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