Clinical trial NCT03652311: Investigating the Efficacy of Caloric Vestibular Stimulation in the Treatment of Substance Use Disorders
Official title: Pilot Investigation of at Home Caloric Vestibular Neuromodulation for Use in Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Substance Use Disorders
Keywords: opiate use disorder
neuromodulation
caloric vestibular stimulation
adjunct therapy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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

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)

Eligibility 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

Primary outcomes:
measure: ODAS score measuring craving severity
timeFrame: 3 months
measure: ODAS score measuring adequacy of treatment
timeFrame: 3 months
Secondary outcomes:
measure: GAD-7 scores measuring anxiety
timeFrame: 3 months
measure: PHQ-9 scores measuring Depressive Symptoms
timeFrame: 3 months
Other outcomes:
measure: Resting State Functional MRI
timeFrame: 6 months
measure: Network Connectivity
timeFrame: 6 months
measure: Possible Structural Changes
timeFrame: 6 months
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Margaret R Rukstalis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.
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.