Brain Responses to Contextual Influences on Drinking Decisions

Alcohol Drinking Clinical Trial

Official title:

Brain Responses to Contextual Influences on Drinking Decisions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04895033
• Other study ID #: STUDY00147117
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: June 2024
• Source: University of Kansas Medical Center
• Contact: Michael Amlung, PhD
• Phone: 785.864.0334
• Email: mamlung[@]ku.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is using functional magnetic resonance imaging (fMRI) to examine brain activity associated with making decisions about drinking alcohol in everyday situations, some of which may involve important activities happening the next day. The secondary aims are to determine whether severity of alcohol-related problems is related to brain activity and alcohol choices and to examine how different areas of the brain interact in connected networks.

Description:

The overall objective of this study is to examine brain activity associated with making decisions about drinking alcohol in everyday situations, some of which may involve important activities happening the next day. The secondary aims are to determine whether severity of alcohol-related problems is related to brain activity and alcohol choices and to examine how different areas of the brain interact in connected networks. The study involves two testing sessions -- a baseline interview conducted virtually or in-person, and a MRI scanning session at University of Kansas Medical Center. Participants (N=80, 50% female, age 21-55) are community adults who report drinking alcohol in excess of NIAAA-recommended weekly drinking limits (i.e., heavy drinkers who consume 14/7+ drinks per week for men/women). Participants will complete hypothetical alcohol purchase tasks during the MRI scan with two conditions being examined. A control condition involves a typical drinking situation with no explicit responsibilities. An experimental condition involves a hypothetical situation with important personally-relevant responsibilities the next day (e.g., a presentation at work, an exam, or caregiving responsibilities).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

1. 21-55 years of age;

2. current heavy alcohol drinking in the past three months, as indicated by reporting consumption of 14 or more drinks per week for men or 7 or more drinks per week for women and at least one heavy drinking episode weekly (5+/4+ drinks in a single occasion for males/females);

3. belong to a category with significant responsibilities, such as being currently employed, a current student, or a caregiver with significant responsibilities;

4. speak English;

5. normal or corrected to normal vision and hearing;

6. able to give informed consent.

Exclusion Criteria:

1. currently engaged in treatment or seeking treatment for alcohol-related problems;

2. major psychiatric illness (psychotic disorder, bipolar disorder, post-traumatic stress disorder);

3. Diagnostic and Statistical Manual Version-5 substance use disorder (except nicotine);

4. attending any in-person session with a positive breath alcohol concentration (BrAC > 0.00%);

5. any contraindications for MRI scanning (e.g., metal in body surgically or accidentally including pacemaker, cochlear implants, aneurysm clips, shrapnel, etc.);

6. history of seizures or anti-seizure medication;

7. history of concussion or other significant brain injury;

8. serious medical illness unsuitable for the MRI scanner based on best clinical judgment

Related Conditions & MeSH terms

• Alcohol Drinking

Intervention

Behavioral:
• Responsibility condition
During the fMRI scan, participants will complete alcohol purchase task paradigm for hypothetical alcohol rewards under two conditions. In the next-day responsibility condition, we will present a vignette describing a drinking scenario in which participants have a significant activity the next day (e.g., a work, family, or academic obligation the next morning) and participants are asked to imagine they are deciding how much they want to drink in this situation. The control condition will use a vignette describing a typical drinking scenario with no explicit responsibilities the next day

Locations

Country	Name	City	State
United States	Cofrin Logan Center for Addiction Research and Treatment	Lawrence	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	University of Kansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol demand	Participants will report how many standard drinks they would consume at varying prices using a hypothetical Alcohol Purchase Task (APT) procedure. The APT is a validated self-report measure of alcohol consumption (in standard drink units) at escalating prices (18 price intervals, ranging from $0 to $80/drink). Responses on APT are analyzed to generate observed and derived indices of alcohol demand, including: intensity (consumption at free price); breakpoint (maximum price for spent for a single drink); Omax (maximum expenditure on alcohol); and Elasticity (proportionate slope of the alcohol demand curve)	During 1 hour MRI scan
Primary	Brain activation	Blood-oxygen-level-dependent (BOLD) activity measured by functional magnetic resonance imaging	During 1 hour MRI scan