Ignite Creation Date:
2024-07-17 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489782
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-28
Brief Title:
Developing a Novel Human Laboratory Paradigm for AUD Medication Screening
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Developing a Novel Human Laboratory Paradigm for AUD Medication Screening
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 intent of the study is to develop two versions of the ability to resist drinking model designed to screen Alcohol Use Disorder AUD medications
Detailed Description:
Proposed is the development of two versions of the ability to resist drinking model designed to screen AUD medications Model 1 will examine the impact of alcohol cues and alcohol availability on the ability to resist drinking and subsequent ad-lib drinking Model 2 alcohol cues alcohol availability low dose prime on the ability to resist drinking and subsequent ad-lib drinking
This study will consist of an intake session a physical exam and two laboratory sessions Each laboratory session will start with the presentation of the primes for Model 1 or 2 following which participants will have the option of initiating an alcohol self-administration session or delaying initiation by five-minute increments for up to 50 minutes in exchange for monetary reinforcement Subsequently the alcohol self-administration session entails a 2-hour period in which participants can choose to drink their preferred beverage or receive monetary compensation for alcohol not consumed
The primary outcome measures for Aim 1 is the latency to start drinking ie ability to resist drinking and amount consumed during the self-administration sessions
This study will consist of an intake session a physical exam and two laboratory sessions Each laboratory session will start with the presentation of the primes for Model 1 or 2 following which participants will have the option of initiating an alcohol self-administration session or delaying initiation by five-minute increments for up to 50 minutes in exchange for monetary reinforcement Subsequently the alcohol self-administration session entails a 2-hour period in which participants can choose to drink their preferred beverage or receive monetary compensation for alcohol not consumed
The primary outcome measures for Aim 1 is the latency to start drinking ie ability to resist drinking and amount consumed during the self-administration sessions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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