Ignite Creation Date:
2024-07-17 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494891
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
Motivation for IV Alcohol Self-Administration in Humans
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Translational Underpinnings of Motivation for Alcohol in Humans
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this translational study is to understand different reasons why people between the ages of 21 and 65 with alcohol use disorder are motivated to self-administer alcohol The main questions it aims to answer are
How does a persons desire for a reward affect their motivation to self-administer alcohol
How does a persons emotions affect their motivation to self-administer alcohol
How does a persons cognitive functioning affect their motivation to self-administer alcohol
Participants will be asked to complete questionnaires about their mood habits and functioning and will complete an IV alcohol administration that will include pressing a button to receive additional doses of IV alcohol
How does a persons desire for a reward affect their motivation to self-administer alcohol
How does a persons emotions affect their motivation to self-administer alcohol
How does a persons cognitive functioning affect their motivation to self-administer alcohol
Participants will be asked to complete questionnaires about their mood habits and functioning and will complete an IV alcohol administration that will include pressing a button to receive additional doses of IV alcohol
Detailed Description:
This study combines alcohol challenge and progressive ratio self-administration methodologies to test the effects of each of the three dimensions of the Addictions Neuroclinical Assessment ANA on motivation for alcohol use The experimental design consists of a translational study in which 210 individuals with current AUD mild-to-severe will complete an intravenous IV alcohol administration followed by a progressive ratio self-administration paradigm where participants must press a button a number of times to receive an infusion of alcohol All participants will be phenotyped for the three dimensions of the ANA including incentive salience negative emotionality and executive dysfunction For these models the primary outcome in the progressive ratio self-administration paradigm will be a breakpoint ie the point in the progressive ratio model at which the participant stops button presses for alcohol and b peak BrAC ie the highest level of BrAC reached in the trial At baseline and after the target BrAC of 006 gdl in the alcohol challenge component of the paradigm participants will report on a alcohol craving b negative mood and c loss of control over drinking All participants will provide blood samples at baseline and at target BrAC 006 gdl for analyses of the proposed exploratory biomarkers of HPA axis activation ACTH cortisol and inflammation IL-6 IL-10 TNF-α CRP The successful completion of this project will advance translational science of AUD by testing the ANA framework within a conceptually rich and valid translational task of motivation for alcohol in humans Advanced data analytic methods ie machine learning and careful attention to AUD severity as a marker to AUD stage will result in clinically useful findings that can inform AUD assessment treatment and biomarker development
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None