AlcoholismNCT00001675
The Effect of Positive and Negative Emotions on Brain Activity in Alcoholics and Nonalcoholics
An observational study of Alcoholism and Healthy, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholism, Healthy
- How many people
- 1,194 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 1998to 23 Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- (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: 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.
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- 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.
Who cannot join
- (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;
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- (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.
- -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.
- -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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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>
Read the detailed 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), 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.
- Conditions
- Alcoholism, Healthy
- Keywords
- Brain Imaging, Affect, Limbic System, Cerebral Blood Volume, Alcoholism, Emotion, Brain, Operant, Autonomic, Relapse, Normal Volunteer
- Medical subject headings
- Alcoholism, Recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2006 (estimated)
- Study start23 Jan 1998
- Study completion23 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 1,194 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Reza Momenan, Ph.D., Principal investigator, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001675
- Sponsor's protocol ID
- 980056
- Other IDs
- 98-AA-0056
- Status last verified
- 23 Dec 2015
- First submitted
- 3 Nov 1999
- Last updated
- 9 Dec 2019
- Results posted
- No
Publications
Breiter HC, Etcoff NL, Whalen PJ, Kennedy WA, Rauch SL, Buckner RL, Strauss MM, Hyman SE, Rosen BR. Response and habituation of the human amygdala during visual processing of facial expression. Neuron. 1996 Nov;17(5):875-87. doi: 10.1016/s0896-6273(00)80219-6.
PubMed 8938120Depue RA, Luciana M, Arbisi P, Collins P, Leon A. Dopamine and the structure of personality: relation of agonist-induced dopamine activity to positive emotionality. J Pers Soc Psychol. 1994 Sep;67(3):485-98. doi: 10.1037//0022-3514.67.3.485.
PubMed 7965602Grant S, London ED, Newlin DB, Villemagne VL, Liu X, Contoreggi C, Phillips RL, Kimes AS, Margolin A. Activation of memory circuits during cue-elicited cocaine craving. Proc Natl Acad Sci U S A. 1996 Oct 15;93(21):12040-5. doi: 10.1073/pnas.93.21.12040.
PubMed 8876259
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Neuroanatomy of Positive and Negative Affect in Alcoholics and Non-Alcoholics
- ClinicalTrials.gov ID
- NCT00001675
- Acronym / sponsor ID
- 980056
- Conditions
- Alcoholism, Healthy
- Keywords
- Brain Imaging, Affect, Limbic System, Cerebral Blood Volume, Alcoholism, Emotion, Brain, Operant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,194 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- 23 Jan 1998
- Study completion
- 23 Dec 2015
- First posted
- 20 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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>
Detailed 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), 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 design
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Exclusion criteria: Same as inpatient alcoholics (item 6 does not apply).
- 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).
- 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.
Key exclusion criteria (13 listed)
- 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.
- 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.
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Background: PubMed 8938120Breiter HC, Etcoff NL, Whalen PJ, Kennedy WA, Rauch SL, Buckner RL, Strauss MM, Hyman SE, Rosen BR. Response and habituation of the human amygdala during visual processing of facial expression. Neuron. 1996 Nov;17(5):875-87. doi: 10.1016/s0896-6273(00)80219-6.
- Background: PubMed 7965602Depue RA, Luciana M, Arbisi P, Collins P, Leon A. Dopamine and the structure of personality: relation of agonist-induced dopamine activity to positive emotionality. J Pers Soc Psychol. 1994 Sep;67(3):485-98. doi: 10.1037//0022-3514.67.3.485.
- Background: PubMed 8876259Grant S, London ED, Newlin DB, Villemagne VL, Liu X, Contoreggi C, Phillips RL, Kimes AS, Margolin A. Activation of memory circuits during cue-elicited cocaine craving. Proc Natl Acad Sci U S A. 1996 Oct 15;93(21):12040-5. doi: 10.1073/pnas.93.21.12040.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reza Momenan, Ph.D. principal investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholism and Healthy, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001675, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.