NCT04157062

An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: West Virginia University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to understand the role of repetitive Transcranial Magnetic Stimulation (rTMS) in reducing opioid and other substance use and craving and improving thinking skills.

Detailed description

The overarching goal of this study is to investigate a form of neuromodulation, rTMS, as an adjunctive treatment for OUD by evaluating the impact of rTMS on substance use, craving and inhibitory control, factors which contribute to relapse. The primary outcome will be the assessment of whether rTMS reduces substance use. Additional exploratory outcomes include the assessment of whether rTMS applied to the DLPFC provides neuromodulatory effects through the assessment of craving, inhibitory control, and functional connectivity via MRI. The targeted sample size for this open-label study, where all enrolled subjects will receive 9 sessions of active rTMS over 3 weeks.

Conditions

• Opioid-use Disorder
• Substance-Related Disorders
• Chemically-Induced Disorders
• Mental Disorder

Interventions

Type	Name	Description
DEVICE	Repetitive Transcranial Magnetic Stimulation (rTMS)	During the rTMS session, an electromagnetic coil is placed against the subjects scalp. The electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the region of the brain involved in memory and thinking.

Timeline

• Start date: 2021-09-30
• Primary completion: 2025-03-19
• Completion: 2025-03-19
• First posted: 2019-11-08
• Last updated: 2025-04-10

Regulatory

• FDA-regulated device study