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

NCT03652311 | Withdrawn FDA Device

• 1 other identifier: IRB00052544
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Substance Use Disorders

Keywords

opiate use disorder; neuromodulation; caloric vestibular stimulation; adjunct therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• GAD-7 scores measuring anxiety

  3 months

• PHQ-9 scores measuring Depressive Symptoms

  3 months

Other Outcomes (3)

• Resting State Functional MRI

  6 months

• Network Connectivity

  6 months

• Possible Structural Changes

  6 months

Study Arms (2)

TNM Device Group

EXPERIMENTAL

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

Sham CVS Group

SHAM COMPARATOR

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

Interventions

ThermoNeuroModulation TNM Device 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.

Also known as: caloric vestibular stimulation, CVS, ThermoNeuroModulationTNM Device

Sham CVS Group; TNM Device Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related 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. doi: 10.1109/JTEHM.2016.2615899. eCollection 2016.

  PMID: 27777829 BACKGROUND

• Gonzalez-Saiz F, Lozano Rojas O, Trujols J, Alcaraz S, Sinol N, Perez 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.

  PMID: 29247974 BACKGROUND

• 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.

  PMID: 24012768 BACKGROUND

• 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.

  PMID: 28294707 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Margaret R Rukstalis, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 29, 2018
• Study Start: November 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: November 26, 2019

Record last verified: 2019-08

Locations

US (1)