Search / Trial NCT00001675

The Effect of Positive and Negative Emotions on Brain Activity in Alcoholics and Nonalcoholics

Launched by NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM (NIAAA) · Apr 19, 2006

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Trial Information

Current as of May 23, 2024

Completed

Keywords

Brain Imaging Affect Limbic System Cerebral Blood Volume Alcoholism Emotion Brain Operant Autonomic Relapse Normal Volunteer

Description

Objective: The purpose of this protocol is two-fold: 1) to determine how individual differences in evoked brain responses relate to generalized trait personality and behavior differences (as assessed by psychometric questionnaire instruments and behavioral measures), and 2) to determine whether individual differences in evoked brain responses relate specifically to genetic polymorphisms in genes governing neurotransmitter activity. Study population: Healthy non-alcoholic adult volunteers, healthy adolescents aged 12 to 17 years (with or without a family history of alcohol use disorder), in...

Gender

All

Eligibility criteria

  • INPATIENT ALCOHOLICS:
  • We will study up to 150 male and 150 female individuals who meet criteria for alcohol use disorders and are between the age of 18 and 65 years. Inpatient alcoholics will be recruited from the NIAAA protocol 05-AA-0121, Assessment and treatment of people with alcohol drinking problems.
  • Inclusion criteria
  • (1) Are physically healthy;
  • (2) Are between 18-65 years of age (since age effects FMRI signal in ways that have not yet been well-characterized);
  • (2) Are right handed.
  • Exclusion criteria:
  • (1) Have ferromagnetic objects in their bodies which might be adversely affected by MRI including implanted pacemakers, medication pumps, aneurysm clips; metallic prostheses (including metal pins and rods, heart valves or cochlear implants, shrapnel fragments, permanent eye liner or small metal fragments in the eye that welders and other metal works may have- any doubt about presence of these objects will result in exclusion from this study), or if candidates are uncomfortable in small closed spaces (have claustrophobia), or cannot lie comfortably on their back for up to one hour;
  • (2) Test HIV positive (since AIDS-related dementia compromises brain function);
  • (3) Are not cleared on a neuromotor examination during the screening physical by the medically responsible staff;
  • (4) Are currently receiving psychotropic medication for emotional distress;
  • (5) Are pregnant or lactating;
  • (6) Have symptoms of alcohol withdrawal as indicated by the most recent measurement within the past 30 days, as measured by the Clinical Institute Withdrawal Assessment (CIWA) score greater than 8;
  • (7) Have active homicidal or suicidal ideation.
  • RECOVERING ALCOHOLICS
  • We will study up to 50 male and 50 female individuals who in the past have met criteria for alcohol use disorders and are between the age of 18 and 65 years. Recovering alcoholics must be at least 3 month without alcohol use, and will be recruited from the NIAAA protocol 05-AA-0121, Assessment and treatment of people with alcohol drinking problems.
  • Inclusion criteria: Same as inpatient alcoholics.
  • Exclusion criteria: Same as inpatient alcoholics.
  • -HEALTHY NON-ALCOHOLICS:
  • We will study up to 150 male and 150 female individuals who have never met criteria for an alcohol use disorder and are between the age of 18 and 65 years and will be recruited from the NIAAA protocol 98-AA-0009, Screening Evaluation for NIAAA Protocols.
  • Inclusion criteria: Same as inpatient alcoholics.
  • Exclusion criteria: Same as inpatient alcoholics (item 6 does not apply).
  • -CHILDREN OF ALCOHOLICS:
  • We will study up to 90 male and 90 female individuals who are biological children of at least one parent who met criteria for alcohol dependence and are between the age of 12 and 17 years.
  • Inclusion criteria: Same as inpatient alcoholics except age range is between 12 and 17 years.
  • Exclusion criteria: Same as inpatient alcoholics except age range is between 12 and 17 years (item 6 does not apply).
  • -CHILDREN OF NON-ALCOHOLICS:
  • We will study up to 90 male and 90 female individuals neither of whose biological parents met criteria for alcohol dependence and are between the age of 12 and 17 years.
  • Inclusion criteria: Same as inpatient alcoholics except age range is between 12 and 17 years.
  • Exclusion criteria: Same as inpatient alcoholics except age range is between 12 and 17 years (item 6 does not apply).
  • -PARENTS OF CHILDREN WHO HAVE AT LEAST ONE PARENT WITH A HISTORY OF ALCOHOL DEPENDENCE:
  • We will study up to 180 individuals who are the parent of a child who has at least one parent with a history of alcohol dependence. The person providing consent may be either a parent with the history of alcohol dependence or a parent without such a history.
  • Inclusion criteria: Legally able to consent for child.
  • Exclusion criteria: None.
  • -PARENTS OF CHILDREN WITH NO FAMILY HISTORY OF ALCOHOL DEPENDENCE
  • We will study up to 180 individuals who are the parent of a child neither of whose parents have a history of alcohol dependence.
  • INCLUSION CRITERIA:
  • Inclusion criteria: Legally able to consent for child.
  • Exclusion criteria: None.

Attachments

readout_NCT00001675_2024-05-23.pdf

4.5 MB

NCT00001675_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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