Terminé

Functional Neuroanatomy of Positive and Negative Affect in Alcoholics and Non-Alcoholics

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Ce qui est collecté

Collecte de données

Qui peut participer

Troubles Mentaux+6

+ Processus pathologiques

+ Conditions pathologiques, signes et symptômes

De 12 à 65 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Observationnel
Date de début : janvier 1998
Voir le détail du protocole

Résumé

Sponsor principalNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
Dernière mise à jour : 9 décembre 2019
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 23 janvier 1998

Date à laquelle le premier participant a commencé l'étude.

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), inpatient or outpatient alcoholics, and recovering alcoholics. Design: In this event-related functional magnetic resonance imaging (fMRI) study we will attempt to evoke positive and negative affect via several different standardized methods including: (1) pictures of emotion-arousing stimuli; (2) pictures of emotional facial expression; (3) cues signaling reward or punishment. This protocol is designed to cover many different functional magnetic imaging studies all using similar techniques to evoke and measure positive and negative affect in the brain. Most subjects will not participate in studies involving all the methods described in the protocol. Outcome measures: The outcome measure is differences in blood oxygenation dependent level (BOLD) signal measured using standard fMRI techniques and analyzed using AFNI software.

NCT00001675
Sponsor principalNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
Dernière mise à jour : 9 décembre 2019
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

1194 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 12 à 65 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Troubles MentauxProcessus pathologiquesConditions pathologiques, signes et symptômesTroubles liés aux substancesTroubles liés à l'alcoolAttributs de la maladieTroubles Induits par Produits ChimiquesAlcoolismeRécurrence

Critères

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.

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOuvrir National Institutes of Health Clinical Center, 9000 Rockville Pike dans Google Maps
Terminé1 Centres d'Étude