Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05778734
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2023-02-27
Brief Title:
StuDy AimED at Increasing AlCohol AbsTinEnce
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
StuDy AimED at Increasing AlCohol AbsTinEnce DEDICATE
Status:
RECRUITING
Status Verified Date:
2024-03
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 clinical trial is to test the feasibility acceptability of an integrated CM-PST intervention in K99 phase and preliminary efficacy in R00 phase vs CM alone to improve treatment efficacy and inform about neural mechanisms of treatment effects in young adults with Alcohol Use Disorder AUD
The aims are as follows
K99 Aim Test feasibility acceptability of a developed CM-PST by meeting these benchmarks 2a Feasibility enroll 20 participants in the new CM-PST in a single-arm pre- and post-study and retain 85 at wk 12 2b Deliver CM-PST at 90 fidelity to intervention protocol 2c Acceptability to participants Achieve mean score 3 on Client Satisfaction Scale Questionnaire and satisfaction from semi-structured interviews
R00 Aim 1 Test preliminary efficacy of CM-PST in a 2-arm pilot RCT Malefemale young adults aged18-24 who meet AUD criteria will be randomized to CM-PST or CM-only control and assessed at baseline 0 3 and 6 months Primary study endpoint will be 3 months
R00 Aim 2 Exploratory Explore potential neural mechanisms of CM-PST effects by fMRI scanning analyses of core regions of the brain circuits regulating positive affect ventral striatum negative affect amygdala and cognitive control dorsolateral prefrontal cortex and connectivity between these core regions
The aims are as follows
K99 Aim Test feasibility acceptability of a developed CM-PST by meeting these benchmarks 2a Feasibility enroll 20 participants in the new CM-PST in a single-arm pre- and post-study and retain 85 at wk 12 2b Deliver CM-PST at 90 fidelity to intervention protocol 2c Acceptability to participants Achieve mean score 3 on Client Satisfaction Scale Questionnaire and satisfaction from semi-structured interviews
R00 Aim 1 Test preliminary efficacy of CM-PST in a 2-arm pilot RCT Malefemale young adults aged18-24 who meet AUD criteria will be randomized to CM-PST or CM-only control and assessed at baseline 0 3 and 6 months Primary study endpoint will be 3 months
R00 Aim 2 Exploratory Explore potential neural mechanisms of CM-PST effects by fMRI scanning analyses of core regions of the brain circuits regulating positive affect ventral striatum negative affect amygdala and cognitive control dorsolateral prefrontal cortex and connectivity between these core regions
Detailed Description:
Study Design Formative K99 Phase we will test feasibility acceptability of integrated CM-PST To test CM-PST we will recruitenroll 20 participants in a single-arm prepost study Participants who meet eligibility will be invited to our clinical lab at UIC for informed consent and baseline measures Consenting participants will receive CM-PST intervention via videoconferences such as zoom in 8 CM-PST individual sessions every week for sessions 1-4 and every other week for sessions 5-8 over 12 weeks Participants will complete the Client Satisfaction Scale survey after each session and 3 mo post-intervention to quantify their overall experiences with this new CM-PST
Preliminary efficacy trial R00 Phase This will be a 2-arm Randomized control trial in young adults aged 18-24 yr who meet AUD criteria Prospective participants who respond to our advertisements will be screened by phone for eligibility and to determine their AUD diagnostic status and severity mild moderate severe Participants who meet eligibility will be invited to our UIC clinical lab for informed consent baseline self-report measures urine alcohol screening and baseline fMRI and then randomized to either CM-PST 42 participants or CM-only 42 participants control group All participants will complete follow-up assessments at 3 6 months with blinded outcome assessors
Preliminary efficacy trial R00 Phase This will be a 2-arm Randomized control trial in young adults aged 18-24 yr who meet AUD criteria Prospective participants who respond to our advertisements will be screened by phone for eligibility and to determine their AUD diagnostic status and severity mild moderate severe Participants who meet eligibility will be invited to our UIC clinical lab for informed consent baseline self-report measures urine alcohol screening and baseline fMRI and then randomized to either CM-PST 42 participants or CM-only 42 participants control group All participants will complete follow-up assessments at 3 6 months with blinded outcome assessors
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