NCT03652311

Investigating the Efficacy of Caloric Vestibular Stimulation in the Treatment of Substance Use Disorders

Pilot Investigation of at Home Caloric Vestibular Neuromodulation for Use in Substance Use Disorders

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine efficacy and effect of CVS (caloric vestibular stimulation)

Detailed description

This study is designed as a nonrandomized, single-blind, sham-controlled trail in which willing participants will receive a 5 day course of twice daily caloric vestibular stimulation (CVS) or sham treatment. CVS involves twice daily sessions of CVS each lasting 15 minutes. The week before the intervention baseline characterization of mood and substance craving will be conducted using standard mood and substance use questionnaires. Prior to treatment beginning participants will undergo structural and functional MR imaging. Participants will also undergo a standard battery of questionnaires, including cognitive testing, mood and affect surveys, and surveys specific to SUD. During each of the 5 treatment days the participants will be asked to fill out questionnaires related to mood and craving symptoms. Participants will be blinded to sham stimulation or the standard CVS protocol. At the end of the 5 day course participants will be scanned again in MRI and asked to fill out the same battery of questions. Consistent with the existing standard of care participants will also receive two urine drug screens (UDS)

Conditions

• Substance Use Disorders

Interventions

Type	Name	Description
DEVICE	ThermoNeuroModulation TNM Device	Study participants will undergo 10 sessions 15 minutes each of Caloric Vestibular Stimulation across 5 days with the FDA approved CVS device. This will be administered in home by study coordinators. Participants will be asked to fill out ODAS, GAD-7, and PHQ-9 on each of the five days during treatment; there is the possibility that other drug specific surveys will be used. Participants will receive two approximately 1 hour MRI scans at the beginning and at the end of the study period.

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2018-08-29
• Last updated: 2019-11-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study