Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629259
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Guanfacine for Alcohol Use Disorder AUD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Guanfacine for Alcohol Use Disorder AUD a Telehealth Approach
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators assess whether guanfacine extended release GXR 3mgd compared with placebo PBO will attenuate drinking and drinking-related factors in N200 men and women with Alcohol Use Disorder AUD across 12-weeks
Detailed Description:
This is a five year study to examine the efficacy of guanfacine extended release GXR 3mgd compared with placebo PBO in reducing drinking in N200 men and women with Alcohol Use Disorder AUD The study will be conducted across two sites for 12-weeks Indiana University will be the primary site and Rutgers University the secondary site Participants at both sites will be randomized to either GXR 3mgd or placebo PBO and titrated to full dose over a three week period After remaining at full dose for 7 weeks a two week schedule will be used to taper participants off the medication During the study the investigators will collect brief reports throughout the day and evening of drinking severity stress craving mood arousal anxiety and emotion regulation at weeks 1 and 2 baseline and weeks 5 and 6 steady state Additionally blood alcohol concentration BAC levels will be collected three times per day for the full 12-weeks Daily encrypted video recordings will be used to monitor medication compliance and participants will also take part in twice weekly remote visits to assess safety vitals collect urines monitor alcohol use and receive weekly Medical Management It is anticipated that guanfacine will demonstrate greater efficacy in women compared to men with AUD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None