跳至主要内容
临床试验/NCT04895033
NCT04895033已完成不适用

Brain Responses to Contextual Influences on Drinking Decisions

University of Kansas Medical Center1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2023年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Alcohol demand

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
21 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •21-55 years of age;
  • •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);
  • •belong to a category with significant responsibilities, such as being currently employed, a current student, or a caregiver with significant responsibilities;
  • •speak English;
  • •normal or corrected to normal vision and hearing;
  • •able to give informed consent.

排除标准

  • •currently engaged in treatment or seeking treatment for alcohol-related problems;
  • •major psychiatric illness (psychotic disorder, bipolar disorder, post-traumatic stress disorder);
  • •Diagnostic and Statistical Manual Version-5 substance use disorder (except nicotine);
  • •attending any in-person session with a positive breath alcohol concentration (BrAC > 0.00%);
  • •any contraindications for MRI scanning (e.g., metal in body surgically or accidentally including pacemaker, cochlear implants, aneurysm clips, shrapnel, etc.);
  • •history of seizures or anti-seizure medication;
  • •history of concussion or other significant brain injury;
  • •serious medical illness unsuitable for the MRI scanner based on best clinical judgment

研究组 & 干预措施

Responsibility vs No Responsibility

Experimental

Within-subjects experimental manipulation of responsibility vs. no-responsibility condition

干预措施: Responsibility condition (Behavioral)

结局指标

主要结局

Alcohol demand

时间窗: During 1 hour MRI scan

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)

Brain activation

时间窗: During 1 hour MRI scan

Blood-oxygen-level-dependent (BOLD) activity measured by functional magnetic resonance imaging

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验