The Effect of Positive and Negative Emotions on Brain Activity in Alcoholics and Nonalcoholics
|First Received Date ICMJE||November 3, 1999|
|Last Updated Date||August 6, 2016|
|Start Date ICMJE||January 1998|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00001675 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The Effect of Positive and Negative Emotions on Brain Activity in Alcoholics and Nonalcoholics|
|Official Title ICMJE||Functional Neuroanatomy of Positive and Negative Affect in Alcoholics and Non-Alcoholics|
This study was designed to learn more about the areas of the brain involved in the experience of positive and negative emotions.
Patients who would like to participate in this study will first undergo a screening process to see if they will be eligible for the study. Patients eligible to participate in the study will go through two sessions.
During session one, researchers will attempt to evoke positive and negative emotions by showing patients slides of different emotion-arousing stimuli (pictures of pleasant and unpleasant scenes). While patients are viewing these slides, researchers will be measuring patient's heart rate, sweating, and eye-blinking.
During session two, patients will undergo an MRI of the brain while seeing similar emotion-arousing pictures as in session one. In addition, patients may be asked to play a simple computer game for a reward of money while researchers use the MRI to measure brain activity.
Researchers hope to develop methods to evoke positive and negative emotions and simultaneously (at the same time) see brain activation in normal volunteers, alcoholics, and recovered alcoholics.<TAB>
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||December 2015|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||12 Years to 65 Years (Child, Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00001675|
|Other Study ID Numbers ICMJE||980056, 98-AA-0056|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||National Institute on Alcohol Abuse and Alcoholism (NIAAA)|
|Study Sponsor ICMJE||National Institute on Alcohol Abuse and Alcoholism (NIAAA)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 2015|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP