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

Substance Use Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03652311
• Other study ID #: IRB00052544
• Status: Withdrawn
• Phase: N/A
• Start date: November 2019
• Est. completion date: January 2020

Study information

• Verified date: August 2019
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

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

Related Conditions & MeSH terms

• Disease
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (4)

Black RD, Rogers LL, Ade KK, Nicoletto HA, Adkins HD, Laskowitz DT. Non-Invasive Neuromodulation Using Time-Varying Caloric Vestibular Stimulation. IEEE J Transl Eng Health Med. 2016 Oct 7;4:2000310. eCollection 2016. — View Citation

González-Saiz F, Lozano Rojas O, Trujols J, Alcaraz S, Siñol N, Pérez de Los Cobos J; Buprenorphine Naloxone Survey Group. Evidence of validity and reliability of the Opiate Dosage Adequacy Scale (ODAS) in a sample of heroin addicted patients in buprenorphine/naloxone maintenance treatment. Drug Alcohol Depend. 2018 Feb 1;183:127-133. doi: 10.1016/j.drugalcdep.2017.10.035. Epub 2017 Dec 11. — View Citation

Gurvich C, Maller JJ, Lithgow B, Haghgooie S, Kulkarni J. Vestibular insights into cognition and psychiatry. Brain Res. 2013 Nov 6;1537:244-59. doi: 10.1016/j.brainres.2013.08.058. Epub 2013 Sep 6. Review. — View Citation

Trojak B, Sauvaget A, Fecteau S, Lalanne L, Chauvet-Gelinier JC, Koch S, Bulteau S, Zullino D, Achab S. Outcome of Non-Invasive Brain Stimulation in Substance Use Disorders: A Review of Randomized Sham-Controlled Clinical Trials. J Neuropsychiatry Clin Neurosci. 2017 Spring;29(2):105-118. doi: 10.1176/appi.neuropsych.16080147. Epub 2017 Mar 15. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Resting State Functional MRI	Blood oxygenation-level dependent signal will be assessed for the whole brain during quiet rest	6 months
Other	Network Connectivity	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.	6 months
Other	Possible Structural Changes	Anatomical analysis including volumetrics will be applied to anatomical MRI scans	6 months
Primary	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
Primary	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	GAD-7 scores measuring anxiety	Measured by GAD-7 questionnaire. Scale range 0-3 with lower scores denoting better outcome measures.	3 months
Secondary	PHQ-9 scores measuring Depressive Symptoms	Measured by PHQ-9 questionnaire. Scale range 0-3 with lower scores denoting better outcome measures.	3 months