NCT04379115

Optimization of NIBS for Treatment of Addiction

Optimization of Non-Invasive Brain Stimulation for Treatment of Addiction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Case Western Reserve University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the effects of transcranial Direct Current Stimulation (tDCS) applied in conjunction with Transcranial Ultrasound (TUS) for the treatment of addiction in opiate use disorder with chronic pain. The investigators hypothesize that there will be a decrease in drug use and improved psychosocial assessments with active stimulation, when compared to sham stimulation.

Conditions

• Opioid-use Disorder
• Chronic Pain

Interventions

Type	Name	Description
DEVICE	Active Comparator: Active tDCS + Active TUS	Device: Active comparator device: Active transcranial Direct Current Stimulation (tDCS). Subjects will receive 20 minutes of active tDCS. During each Active stimulation session, stimulation will be applied for the full 20 minutes. Device: Active comparator device: Active Transcranial Ultrasound (TUS). Subjects will receive 20 minutes of active Transcranial Ultrasound (TUS). During active stimulation the (TUS) will be active for the full 20 minutes.
DEVICE	Sham Comparator: Sham tDCS + Sham TUS	Device: SHAM Comparator Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of sham tDCS. In the sham group, the tDCS device will not be active for the full 20 minutes. Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of sham TUS. During sham stimulation the ultrasound will not be active for the full 20 minutes.

Timeline

• Start date: 2021-04-04
• Primary completion: 2027-10-31
• Completion: 2027-10-31
• First posted: 2020-05-07
• Last updated: 2026-03-04

Locations

3 sites across 1 country: United States