Substance Use DisordersNCT03652311
Investigating the Efficacy of Caloric Vestibular Stimulation in the Treatment of Substance Use Disorders
A study testing ThermoNeuroModulation TNM Device in people with Substance Use Disorders, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to determine efficacy and effect of CVS (caloric vestibular stimulation) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- ThermoNeuroModulation TNM Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2019to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Pilot Investigation of at Home Caloric Vestibular Neuromodulation for Use in Substance Use Disorders
The purpose of this study is to determine efficacy and effect of CVS (caloric vestibular stimulation)
Read the 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)
- Conditions
- Substance Use Disorders
- Being tested
- ThermoNeuroModulation TNM Device
- Keywords
- opiate use disorder, neuromodulation, caloric vestibular stimulation, adjunct therapy
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermoNeuroModulation TNM DeviceDevice
Also called caloric vestibular stimulation, CVS, ThermoNeuroModulationTNM 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: ThermoNeuroModulation TNM Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Secondary outcomes (2)
GAD-7 scores measuring anxiety
Measured by GAD-7 questionnaire. Scale range 0-3 with lower scores denoting better outcome measures.
Measured: 3 months
PHQ-9 scores measuring Depressive Symptoms
Measured by PHQ-9 questionnaire. Scale range 0-3 with lower scores denoting better outcome measures.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study startNov 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Why it stopped: Suspended temporarily due to staff changes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaret R Rukstalis, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652311
- Sponsor's protocol ID
- IRB00052544
- Status last verified
- Aug 2019
- First submitted
- 17 Aug 2018
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 27777829Gonzalez-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.
PubMed 29247974Gurvich 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.
PubMed 24012768Trojak 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.
PubMed 28294707
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Investigation of at Home Caloric Vestibular Neuromodulation for Use in Substance Use Disorders
- ClinicalTrials.gov ID
- NCT03652311
- Acronym / sponsor ID
- IRB00052544
- Conditions
- Substance Use Disorders
- Keywords
- opiate use disorder, neuromodulation, caloric vestibular stimulation, adjunct therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Suspended temporarily due to staff changes
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| TNM Device Group | Experimental | Device: ThermoNeuroModulation TNM DeviceIn 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. |
| Sham CVS Group | Sham comparator | Device: ThermoNeuroModulation TNM DeviceIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThermoNeuroModulation TNM DeviceAlso: caloric vestibular stimulation, CVS, ThermoNeuroModulationTNM DeviceStudy 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. | Device | Sham CVS Group, TNM Device Group |
Primary outcome
ODAS score measuring craving severity
Time frame: 3 months
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.
ODAS score measuring adequacy of treatment
Time frame: 3 months
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.
2 secondary outcomes
GAD-7 scores measuring anxiety
Time frame: 3 months
PHQ-9 scores measuring Depressive Symptoms
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Background: PubMed 27777829Black 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.
- Background: PubMed 29247974Gonzalez-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.
- Background: PubMed 24012768Gurvich 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.
- Background: PubMed 28294707Trojak 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.
Related trials for Substance Use Disorders
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret R Rukstalis, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ThermoNeuroModulation TNM Device in people with Substance Use Disorders, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ODAS score measuring craving severity (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03652311, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.