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

NCT03652311 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-11-26

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Margaret R Rukstalis, MD · Wake Forest University Health Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-30
Primary Completion
2020-01-31
Completion
2020-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03652311 on ClinicalTrials.gov