Neural Substrates of Approach-Avoidance Conflict

NCT02119624 | Completed

• 2 other identifiers: 14009414-AA-0094
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Alcoholism; fMRI; Rewarding Mediating System

Keywords

Neural Networks; Alcoholism; fMRI; Reward; Addiction

Outcome Measures

Primary Outcomes (1)

• fMRI BOLD signal differences between heavy and light drinkers during reward and threat task.

  fMRI and behavioral differences between light drinkers and heavy drinkers.

  Mainly the fMRI and behavioral data collected at the time of enrollment

Study Arms (2)

1

Healthy non-treatment-seeking heavy drinkers

2

Healthy light drinkers

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy non-treatment-seeking heavy drinkers and healthy light drinkers aged 21 to 60.@@@

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• 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;
• Not seeking treatment for their alcohol consumption.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• 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.

  PMID: 7666173 BACKGROUND

• Alvarez 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.

  PMID: 18550763 BACKGROUND

• Aupperle 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.

  PMID: 21319496 BACKGROUND

• Grodin 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.

  PMID: 30143454 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Alcoholism; Behavior, Addictive

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Reza Momenan, Ph.D.

  National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: April 21, 2014
• Study Start: July 23, 2014
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: January 26, 2021

Record last verified: 2021-01

Locations

US (1)