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

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

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)

Inclusion Criteria:

• Subjects will have a diagnosed SUD (including but not limited to Opiate, Alcohol, Cocaine, Nicotine, or Amphetamine Use Disorders).
• Subjects will be between the age of 17 and 50 years old
• Subjects will have been abstinent on a stable treatment regimen for at least 4 weeks
• Subjects will be able to sit still for MRI imaging
• Subjects will be able to read and complete survey questionnaires
• Subjects will reliably be abstinent from their drug of choice through the 5 day intervention as determined by the discretion of a clinician

Exclusion Criteria:

• Subjects will be excluded for comorbid neuropathology (eg history of stroke or TBI)
• Subjects will be excluded if they are at high risk for relapse as determined by a clinician
• Subjects will be excluded if they are unable to tolerate the CVS devise
• Subjects will be excluded if they have malformations of or existing trauma to the external auditory canal