Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585709
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
OUD Opioid Use Disorder Target Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Development and Validation of Neural Targets in Opioid Use Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
In this research study the investigators will work with 80-participants with opioid use disorder who are starting treatment with the medication buprenorphine and are trying to quit using opioids
The investigators are trying to learn two things
1 Can an MRI brain marker be used to predict which participants will be successful in quitting opioids with buprenorphine
2 Does adjunctive treatment with repetitive Transcranial Magnetic Stimulation rTMS help people quit using opioids more than a sham placebo version of rTMS
In order to complete the study the investigators will ask participants to
Complete an MRI within 5-days of starting buprenorphine and again after they are on a full stable dose 1-3 weeks later
Undergo study-treatment with 50-sessions of either real or placebo rTMS in as little as 1-week 10-sessions-per-day for five days or as long as over 6-weeks
Meet with the investigators once per week over the following 12-weeks to see if the participants have been able to quit using opioids over that time
The investigators are trying to learn two things
1 Can an MRI brain marker be used to predict which participants will be successful in quitting opioids with buprenorphine
2 Does adjunctive treatment with repetitive Transcranial Magnetic Stimulation rTMS help people quit using opioids more than a sham placebo version of rTMS
In order to complete the study the investigators will ask participants to
Complete an MRI within 5-days of starting buprenorphine and again after they are on a full stable dose 1-3 weeks later
Undergo study-treatment with 50-sessions of either real or placebo rTMS in as little as 1-week 10-sessions-per-day for five days or as long as over 6-weeks
Meet with the investigators once per week over the following 12-weeks to see if the participants have been able to quit using opioids over that time
Detailed Description:
None
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