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

Not Applicable

Withdrawn

Brief 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)

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Sham CVS Group	ThermoNeuroModulation TNM Device	In this arm participants will receive 5 sessions of twice daily sessions of 15 minutes of sham stimulation with the ThermoNeuroModulation TNM Device. The ThermoNeuroModulation TNM device will be fitted and turned on in a random paradigm that has no demonstrated efficacy. Participants will continue with the standard therapy that they are receiving.
TNM Device Group	ThermoNeuroModulation TNM Device	In this arm participants will receive 5 sessions of twice daily treatments of 15 minutes of caloric vestibular stimulation (CVS) using the ThermoNeuroModulation TNM Device. In addition, participants will continue with the standard therapy that they are receiving.

Primary Outcome Measures

Name	Time	Method
ODAS score measuring craving severity	3 months	Measured items 5a and 5b of the ODAS (Opiate Dosage Adequacy Scale) that deal with craving and craving severity directly. It is scored by Likert-type scores ranging from 1 to 5. The higher the score the higher the craving severity A reduction in craving and craving severity will be the primary outcome. This single dimension is important for risk of relapse, but does not by itself represent treatment adequacy as a whole.
ODAS score measuring adequacy of treatment	3 months	Measured by ODAS (Opiate Dosage Adequacy Scale).The ODAS clinical interview includes 10 items that evaluate six components of the construct "dose adequacy." Questions on the ODAS that measure symptom frequency are coded with Likert-type scores ranging from 1 to 5. Questions that measure symptom severity are coded on a visual analogue scale (VAS) using the same score range. The dimensional model provides a total score derived from a weighted sum of the scores of the individual items. The higher the total score, the more "adequate" the dose is considered to be. An increase in the total ODAS dimensional model score will indicate improved adequacy of treatment. This adequacy includes craving, but also represents multiple dimensions relevant to the treatment of OUD. An improvement of adequacy, irrespective of craving, is indicative of an effective treatment, and would indicate an effect of treatment on a feature of OUD other than craving.

Secondary Outcome Measures

Name	Time	Method
PHQ-9 scores measuring Depressive Symptoms	3 months	Measured by PHQ-9 questionnaire. Scale range 0-3 with lower scores denoting better outcome measures.
GAD-7 scores measuring anxiety	3 months	Measured by GAD-7 questionnaire. Scale range 0-3 with lower scores denoting better outcome measures.

Locations (1): Wake Forest University Health Sciences
🇺🇸
Winston-Salem, North Carolina, United States