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



Status:Not yet recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:3/10/2019
Start Date:April 2019
End Date:May 2019
Contact:Margaret R Rukstalis, MD
Email:mrukstal@wakehealth.edu
Phone:(336) 716-3426

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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
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Principal Investigator: Margaret R Rudstalis, MD
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Winston-Salem, NC
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