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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652311
Recruitment Status : Withdrawn (Suspended temporarily due to staff changes)
First Posted : August 29, 2018
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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

Condition or disease Intervention/treatment Phase
Substance Use Disorders Device: ThermoNeuroModulation TNM Device Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: Pilot Investigation of at Home Caloric Vestibular Neuromodulation for Use in Substance Use Disorders
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Experimental: 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.
Device: 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.
Other Names:
  • caloric vestibular stimulation
  • CVS
  • ThermoNeuroModulationTNM Device

Sham Comparator: 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.
Device: 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.
Other Names:
  • caloric vestibular stimulation
  • CVS
  • ThermoNeuroModulationTNM Device




Primary Outcome Measures :
  1. ODAS score measuring craving severity [ Time Frame: 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.

  2. ODAS score measuring adequacy of treatment [ Time Frame: 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 :
  1. GAD-7 scores measuring anxiety [ Time Frame: 3 months ]
    Measured by GAD-7 questionnaire. Scale range 0-3 with lower scores denoting better outcome measures.

  2. PHQ-9 scores measuring Depressive Symptoms [ Time Frame: 3 months ]
    Measured by PHQ-9 questionnaire. Scale range 0-3 with lower scores denoting better outcome measures.


Other Outcome Measures:
  1. Resting State Functional MRI [ Time Frame: 6 months ]
    Blood oxygenation-level dependent signal will be assessed for the whole brain during quiet rest

  2. Network Connectivity [ Time Frame: 6 months ]
    BOLD signal correlation of regions of interest will be conducted. Secondary network statistics including small-worldness, modularity, and others will be used to describe the network architecture.

  3. Possible Structural Changes [ Time Frame: 6 months ]
    Anatomical analysis including volumetrics will be applied to anatomical MRI scans



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652311


Locations
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United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Margaret R Rukstalis, MD Wake Forest University Health Sciences

Publications:
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03652311    
Other Study ID Numbers: IRB00052544
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Wake Forest University Health Sciences:
opiate use disorder
neuromodulation
caloric vestibular stimulation
adjunct therapy
Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders