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NCT03907644 · ClinicalTrials.gov registry record · NA
Frontoparietal Synchronization to Modulate Drug Craving in Opioid Use Disorder
A NA study, sponsored by Laureate Institute for Brain Research.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT03907644: Completed NA study, sponsored by Laureate Institute for Brain Research.
NCT03907644 is a NA study that has completed, run by Laureate Institute for Brain Research. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03907644, a NA study, has completed, sponsored by Laureate Institute for Brain Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study Summary
Opioid use disorder (OUD) is among the costliest and deadliest substance use disorders (SUDs) in the US and world-wide. Opioids were involved in 42,249 deaths in the US in 2016, which were more than deaths due to road accidents and gun violence combined. Opioid overdose deaths were five times higher in 2016 than 1999. Meanwhile, the treatment options for OUD are limited and long-term efficacy is poor. There is a hope that recent advances in understanding of the cognitive neuroscience underlying addictive behavior, like drug craving and its regulatory processes, can bring new opportunities for more effective and personalized treatment options for OUD. Drug craving is the signature aspect of OUD as well as other SUDs which has been associated with continued drug use and relapse. In previous studies, the investigators have shown significant response to drug related cues in both frontoparietal and limbic areas including amygdala and ventral striatum. In a recent pilot study, the investigators showed significant lower connectivity between amygdala and frontoparietal areas, including dorsolateral prefrontal cortex (DLPFC) and inferior parietal cortex (IPC), major nodes of the executive control network (ECN), in patients with OUD compared with healthy controls. The central role of the ECN is to perform top down regulation of subcortical limbic areas during self-control, emotion-regulation, and response- inhibition tasks. These processes are well known to be affected in different psychopathologies including SUDs. There is a growing body of evidence that external frontoparietal synchronization (FPS) with transcranial alternating current stimulation (tACS) can potentially modulate connectivity within ECN and between ECN and limbic areas. This may improve some aspects of executive function and top down regulation. tACS is a low-cost and scalable non-invasive brain stimulation technology without any serious side effects. The procedure involves the transcranial delivery of low l
Primary Outcome
Drug Cue Reactivity BOLD Signal is measured as average blood oxygen level dependent (BOLD) signal difference with voxel-wise analysis in the regions of interests (ROIs) (prefrontal cortex parcels, insula segments, striatum nuclei, thalamus nuclei and extended amygdala nuclei) in craving \> neutral contrast in drug cue exposure fMRI task with blocks of neutral and drug related images
Interventions
- DEVICE Transcranial Alternating Current Stimulation (tACS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-03-15 |
| Est. Completion | 2023-06-15 |
| Phase | NA |
What the finished NCT03907644 record still lists
NCT03907644 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Transcranial Alternating Current Stimulation (tACS) is the first listed.
NCT03907644 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03907644 about?
NCT03907644 is a clinical study titled "Frontoparietal Synchronization to Modulate Drug Craving in Opioid Use Disorder". Opioid use disorder (OUD) is among the costliest and deadliest substance use disorders (SUDs) in the US and world-wide. Opioids were involved in 42,249 deaths in the US in 2016, which were more than deaths due to road accidents and gun violence combined. Opioid overdose deaths were five times higher...
What is the current status of trial NCT03907644?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2019-03-15. Estimated completion is 2023-06-15.
What interventions are being tested in trial NCT03907644?
The interventions under investigation include: Transcranial Alternating Current Stimulation (tACS) (DEVICE).
Who is sponsoring clinical trial NCT03907644?
This trial is sponsored by Laureate Institute for Brain Research, which has 45 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03907644's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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