AlcoholismNCT02119624
Neural Substrates of Approach-Avoidance Conflict
An observational study of Alcoholism and fMRI, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
Background: People who are dependent on alcohol drink even when they know something bad might happen. Researchers want to learn more about why they do this. Objectives: To study brain response when a person plays a game in different threat conditions. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Alcoholism, fMRI, Rewarding Mediating System
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2014to 1 Sep 2020
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Healthy non-treatment-seeking heavy drinkers and healthy light drinkers aged 21 to 60.@@@
Who may be able to join
- In good health as determined by medical history, physical exam, ECG, and lab tests;
- Between 21 and 60 years of age;
- Currently consuming on average 1-10 drinks per week for females and on average 1-14 drinks per week for males, (averaging over the 90 days recorded in the Alcohol Timeline Followback);
- Right handed.
- In good health as determined by medical history, physical exam, ECG, and lab tests;
- Between 21 and 60 years of age;
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- Currently consuming on average 15+ drinks per week for females and on average 20+ drinks per week for males, as determined by the 90-day Alcohol Timeline Followback, or fulfilled DSM-IV-TR criteria for current alcohol dependence or DSM-5 criteria for current alcohol use disorder;
- Right-handed;
- Clinical Institute Withdrawal Assessment Alcohol Revised (CIWA-AR) score less than 8;
- Not seeking treatment for their alcohol consumption.
Who cannot join
- Have liver function tests (AST, ALT, GGT, ALP) 3-times the upper limit of normal (ULN); or have Total Bilirubin above 1.5 ULN and Albumin below 3.5 g/dl;
- Have fulfilled DSM-IV-TR or DSM-5 criteria for alcohol dependence or alcohol use disorder (past or current) at any time, or other current substance dependence or substance use disorder (excluding nicotine);
- Report having received any medication to treat a psychiatric disorder within the past year, have a past or present diagnosis of a psychotic or bipolar disorder, or have ever had a head injury requiring hospitalization;
- Weigh over 330 pounds;
- Are pregnant, as determined by a positive pregnancy test, or breast feeding; Report to have a facial, body, and limb flushing response to the consumption of alcohol, as determined by the Alcohol Flushing Questionnaire;
- Report to have a "facial flushing" response to the consumption of alcohol
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- 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;
- Medical illnesses (such as diabetes or stage 2 hypertension systolic blood pressure greater than or equal to 160 mm Hg or diastolic blood pressure greater than or equal to 100 mm Hg) or neurological illnesses (carpal tunnel syndrome; migraine headaches; seizure disorders) likely to interfere with the study;
- Endorse more than 3 symptoms on the Yale Food Addiction Scale;
- Have colorblindness.
- All exclusion criteria for Light Drinkers except for Light Drinker exclusion criterion number two. For Heavy Drinkers this exclusion criterion will read:
- Have fulfilled DSM-IV-TR or DSM-5 criteria for any current substance dependence or current substance use disorder (excluding alcohol or nicotine).
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: Neural Substrate of Approach-Avoidance Conflict
Background:
- People who are dependent on alcohol drink even when they know something bad might happen. Researchers want to learn more about why they do this.
Read more
Objectives:
- To study brain response when a person plays a game in different threat conditions.
Eligibility:
- Healthy right-handed adult heavy drinkers age 21 60
- Healthy right-handed adult light drinkers age 21 60
Design:
- Participants will be screened with medical history, physical exam, and blood and urine tests. They will have an EKG and psychiatric interview.
- Participants will have one or two clinic visits.
- Participants will be asked about their alcohol drinking.
- They will choose a snack and alcoholic beverage that they must drink in 5 minutes. After their breath alcohol content (BrAC) is zero, they will play a game in the MRI scanner.
- The scanner is a metal cylinder that takes pictures of the brain. Participants lie on a table that slides in and out of the cylinder. They will be in it for about 90 minutes, lying still for up to 20 minutes.
- During the MRI, participants will play a simple computer game to earn food or drink points under different threats of electric shock. Points can be exchanged for food or alcohol after the game. Sometimes, participants will receive a mild electric shock through a metal disk on the wrist. Electric shocks will only happen if the participant tries to earn a reward point.
- After the MRI, participants use their points for another drink and snack. They will stay at the clinic until their BrAC is low, usually within 3 hours. Participants cannot drive themselves home.
- Participants will have a follow-up phone call the next day.
Read the detailed description
Objective: Continued drug seeking despite knowledge of adverse consequences is a hallmark of addiction. To model this behavior, we will refine the parameters of a modified Monetary Incentive Delay (MID) task that will allow us to investigate neural substrates of approach-avoidance conflict resolution. We will then use this task to investigate functional magnetic resonance imaging (fMRI) brain activation during pursuit of reward in heavy and light drinkers.
Study Population: Healthy non-treatment-seeking heavy drinkers and healthy light drinkers aged 21 to 60.
Design: The study will require 1 to 2 visits. Subjects will play a modified MID task called Reward Incentive Delay with Shock (RIDS) to measure motivation to earn cue reward points in conditions that are signaled to be safe or associated with a threat. After playing the RIDS task subjects will be able to self-administer alcohol and/or food based on the reward points earned during the task.
Outcome measures: The outcome measures are differences in behavioral task performance and in blood oxygenation dependent level (BOLD) signal measured using standard fMRI techniques and analyzed using AFNI software.
- Conditions
- Alcoholism, fMRI, Rewarding Mediating System
- Keywords
- Neural Networks, Alcoholism, fMRI, Reward, Addiction
- Medical subject headings
- Alcoholism, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Healthy non-treatment-seeking heavy drinkers | |
| 2 | Healthy light drinkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI BOLD signal differences between heavy and light drinkers during reward and threat task.
fMRI and behavioral differences between light drinkers and heavy drinkers.
Measured: Mainly the fMRI and behavioral data collected at the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study start23 Jul 2014
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 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
- NCT02119624
- Sponsor's protocol ID
- 140094
- Other IDs
- 14-AA-0094
- Status last verified
- Jan 2021
- First submitted
- 17 Apr 2014
- Last updated
- 26 Jan 2021
- Results posted
- No
Publications
Adolphs R, Tranel D, Damasio H, Damasio AR. Fear and the human amygdala. J Neurosci. 1995 Sep;15(9):5879-91. doi: 10.1523/JNEUROSCI.15-09-05879.1995.
PubMed 7666173Alvarez RP, Biggs A, Chen G, Pine DS, Grillon C. Contextual fear conditioning in humans: cortical-hippocampal and amygdala contributions. J Neurosci. 2008 Jun 11;28(24):6211-9. doi: 10.1523/JNEUROSCI.1246-08.2008.
PubMed 18550763Aupperle RL, Paulus MP. Neural systems underlying approach and avoidance in anxiety disorders. Dialogues Clin Neurosci. 2010;12(4):517-31. doi: 10.31887/DCNS.2010.12.4/raupperle.
PubMed 21319496Grodin EN, Sussman L, Sundby K, Brennan GM, Diazgranados N, Heilig M, Momenan R. Neural Correlates of Compulsive Alcohol Seeking in Heavy Drinkers. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 Dec;3(12):1022-1031. doi: 10.1016/j.bpsc.2018.06.009. Epub 2018 Jul 9.
PubMed 30143454
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Substrate of Approach-Avoidance Conflict
- ClinicalTrials.gov ID
- NCT02119624
- Acronym / sponsor ID
- 140094
- Conditions
- Alcoholism, fMRI, Rewarding Mediating System
- Keywords
- Neural Networks, Alcoholism, fMRI, Reward, Addiction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- 23 Jul 2014 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 21 Apr 2014 (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.
Background:
- People who are dependent on alcohol drink even when they know something bad might happen. Researchers want to learn more about why they do this.
Objectives:
- To study brain response when a person plays a game in different threat conditions.
Eligibility:
- Healthy right-handed adult heavy drinkers age 21 60
- Healthy right-handed adult light drinkers age 21 60
Design:
- Participants will be screened with medical history, physical exam, and blood and urine tests. They will have an EKG and psychiatric interview.
- Participants will have one or two clinic visits.
- Participants will be asked about their alcohol drinking.
- They will choose a snack and alcoholic beverage that they must drink in 5 minutes. After their breath alcohol content (BrAC) is zero, they will play a game in the MRI scanner.
- The scanner is a metal cylinder that takes pictures of the brain. Participants lie on a table that slides in and out of the cylinder. They will be in it for about 90 minutes, lying still for up to 20 minutes.
- During the MRI, participants will play a simple computer game to earn food or drink points under different threats of electric shock. Points can be exchanged for food or alcohol after the game. Sometimes, participants will receive a mild electric shock through a metal disk on the wrist. Electric shocks will only happen if the participant tries to earn a reward point.
- After the MRI, participants use their points for another drink and snack. They will stay at the clinic until their BrAC is low, usually within 3 hours. Participants cannot drive themselves home.
- Participants will have a follow-up phone call the next day.
Detailed description
Objective: Continued drug seeking despite knowledge of adverse consequences is a hallmark of addiction. To model this behavior, we will refine the parameters of a modified Monetary Incentive Delay (MID) task that will allow us to investigate neural substrates of approach-avoidance conflict resolution. We will then use this task to investigate functional magnetic resonance imaging (fMRI) brain activation during pursuit of reward in heavy and light drinkers.
Study Population: Healthy non-treatment-seeking heavy drinkers and healthy light drinkers aged 21 to 60.
Design: The study will require 1 to 2 visits. Subjects will play a modified MID task called Reward Incentive Delay with Shock (RIDS) to measure motivation to earn cue reward points in conditions that are signaled to be safe or associated with a threat. After playing the RIDS task subjects will be able to self-administer alcohol and/or food based on the reward points earned during the task.
Outcome measures: The outcome measures are differences in behavioral task performance and in blood oxygenation dependent level (BOLD) signal measured using standard fMRI techniques and analyzed using AFNI software.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Healthy non-treatment-seeking heavy drinkers |
| 2 | – | –Healthy light drinkers |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Healthy non-treatment-seeking heavy drinkers and healthy light drinkers aged 21 to 60.@@@
Key inclusion criteria (10 listed)
- In good health as determined by medical history, physical exam, ECG, and lab tests;
- Between 21 and 60 years of age;
- Currently consuming on average 15+ drinks per week for females and on average 20+ drinks per week for males, as determined by the 90-day Alcohol Timeline Followback, or fulfilled DSM-IV-TR criteria for current alcohol dependence or DSM-5 criteria for current alcohol use disorder;
- Right-handed;
- Clinical Institute Withdrawal Assessment Alcohol Revised (CIWA-AR) score less than 8;
Key exclusion criteria (12 listed)
- Have liver function tests (AST, ALT, GGT, ALP) 3-times the upper limit of normal (ULN); or have Total Bilirubin above 1.5 ULN and Albumin below 3.5 g/dl;
- Have fulfilled DSM-IV-TR or DSM-5 criteria for alcohol dependence or alcohol use disorder (past or current) at any time, or other current substance dependence or substance use disorder (excluding nicotine);
- Report having received any medication to treat a psychiatric disorder within the past year, have a past or present diagnosis of a psychotic or bipolar disorder, or have ever had a head injury requiring hospitalization;
- Weigh over 330 pounds;
- Are pregnant, as determined by a positive pregnancy test, or breast feeding; Report to have a facial, body, and limb flushing response to the consumption of alcohol, as determined by the Alcohol Flushing Questionnaire;
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
fMRI BOLD signal differences between heavy and light drinkers during reward and threat task.
Time frame: Mainly the fMRI and behavioral data collected at the time of enrollment
fMRI and behavioral differences between light drinkers and heavy drinkers.
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 26 Jan 2021.
- Background: PubMed 7666173Adolphs R, Tranel D, Damasio H, Damasio AR. Fear and the human amygdala. J Neurosci. 1995 Sep;15(9):5879-91. doi: 10.1523/JNEUROSCI.15-09-05879.1995.
- Background: PubMed 18550763Alvarez RP, Biggs A, Chen G, Pine DS, Grillon C. Contextual fear conditioning in humans: cortical-hippocampal and amygdala contributions. J Neurosci. 2008 Jun 11;28(24):6211-9. doi: 10.1523/JNEUROSCI.1246-08.2008.
- Background: PubMed 21319496Aupperle RL, Paulus MP. Neural systems underlying approach and avoidance in anxiety disorders. Dialogues Clin Neurosci. 2010;12(4):517-31. doi: 10.31887/DCNS.2010.12.4/raupperle.
- Derived from this study: PubMed 30143454Grodin EN, Sussman L, Sundby K, Brennan GM, Diazgranados N, Heilig M, Momenan R. Neural Correlates of Compulsive Alcohol Seeking in Heavy Drinkers. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 Dec;3(12):1022-1031. doi: 10.1016/j.bpsc.2018.06.009. Epub 2018 Jul 9.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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 fMRI, 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 10 inclusion and 12 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 26 Jan 2021. 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.
What does the primary outcome measure?
fMRI BOLD signal differences between heavy and light drinkers during reward and threat task. (time frame: Mainly the fMRI and behavioral data collected at the time of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02119624, which also lists 4 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 26 Jan 2021.