Clinical trial NCT04895033: Brain Responses to Contextual Influences on Drinking Decisions
Official title: Brain Responses to Contextual Influences on Drinking Decisions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcohol Drinking
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: University of Kansas
First posted: 2021-05-20
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study uses a within-subjects design with all participants completing the no-responsibility and responsibility conditions.
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Alcohol demand
timeFrame: During 1 hour MRI scan
measure: Brain activation
timeFrame: During 1 hour MRI scan
Secondary outcomes:
Other outcomes:
Locations:
city: Lawrence
country: United States
facility: Cofrin Logan Center for Addiction Research and Treatment
state: Kansas
Study officials:
affiliation: University of Kansas
name: Michael Amlung, PhD
role: PRINCIPAL_INVESTIGATOR
References: