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

Wake Forest University (WFU)

Status: Withdrawn

Conditions: Substance Use Disorders

Treatments: Device: ThermoNeuroModulation TNM Device

Study type: Interventional

Funder types: Other

Identifiers

NCT03652311

IRB00052544

Details and patient eligibility

About

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

Full 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)

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

TNM Device Group

Experimental group

Description:

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.

Treatment:

Device: ThermoNeuroModulation TNM Device

Sham CVS Group

Sham Comparator group

Description:

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.

Treatment:

Device: ThermoNeuroModulation TNM Device