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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2020-01-31

Brief Summary

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

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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)

Conditions

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Substance Use Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants will not know if they are receiving therapeutic CVS or sham stimulation.

Participant survey responses will be blinded during analysis and only the use of non-informative catalogue will be used. This will eliminate bias in the analysis of the survey data.

Study Groups

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TNM Device Group

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.

Group Type EXPERIMENTAL

ThermoNeuroModulation TNM Device

Intervention Type 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.

Sham CVS Group

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.

Group Type SHAM_COMPARATOR

ThermoNeuroModulation TNM Device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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caloric vestibular stimulation CVS ThermoNeuroModulationTNM Device

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No