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

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

Detailed Description
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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)

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

Conditions
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Substance Use Disorders

Intervention / Treatment
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* Device: ThermoNeuroModulation TNM Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TNM Device Group<br>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. | Device: ThermoNeuroModulation TNM Device<br>* 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.<br>* Other names: ThermoNeuroModulationTNM Device;|
| Sham Comparator: Sham CVS Group<br>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. | Device: ThermoNeuroModulation TNM Device<br>* 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.<br>* Other names: ThermoNeuroModulationTNM Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ODAS score measuring craving severity | 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. | 3 months | 
| ODAS score measuring adequacy of treatment | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GAD-7 scores measuring anxiety | Measured by GAD-7 questionnaire. Scale range 0-3 with lower scores denoting better outcome measures. | 3 months | 
| PHQ-9 scores measuring Depressive Symptoms | Measured by PHQ-9 questionnaire. Scale range 0-3 with lower scores denoting better outcome measures. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opiate use disorder, neuromodulation, caloric vestibular stimulation, adjunct therapy