Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432465
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-23
Brief Title:
tDCS to Decrease Opioid Relapse UH3
Sponsor:
Butler Hospital
Organization:
Butler Hospital
Study Overview
Official Title:
tDCS to Decrease Opioid Relapse UH3
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Investigators will measure behavioral and brain responses following transcranial direct current stimulation tDCS to the dorsolateral prefrontal cortex DLPFC anode on right DLPFC cathode on the left DLPFC delivered during cognitive control network CCN priming In Phase I the EEG provided validation of expected changes in these networks following tDCS stimulation of the DLPFC In this current phase II the investigators will perform a larger randomized clinical trial RCT active vs sham control to address long-term neurobehavioral outcomes including opioid relapse craving and sustained EEG changes
Detailed Description:
Investigators will perform an RCT in 100 opioid dependent participants who recently initiated buprenorphine or methadone Participants will be randomized to receive five sessions of tDCSCCN priming stimulation vs sham tDCSCCN priming Participants will be assessed three times using electroencephalographic EEG once prior to tDCSCCN priming right after the completion of 5 sessions of tDCSCCN priming one week later and again 10 weeks later
This phase will address long-term 3- and 6-month neurobehavioral outcomes including opioid relapse craving and sustained EEG changes during a paradigm that challenges networks associated with craving CR and cognitive control CCN During the 24 weeks of buprenorphine or methadone maintenance treatment the investigators will examine our primary clinical outcome relapse opioid use on 4 days per month and having an opioid positive urine screen as well as days of opioid use
This phase will address long-term 3- and 6-month neurobehavioral outcomes including opioid relapse craving and sustained EEG changes during a paradigm that challenges networks associated with craving CR and cognitive control CCN During the 24 weeks of buprenorphine or methadone maintenance treatment the investigators will examine our primary clinical outcome relapse opioid use on 4 days per month and having an opioid positive urine screen as well as days of opioid use
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 4UH3DA047793 | NIH | None | httpsreporternihgovquickSearch4UH3DA047793 |