Nexalin Therapy as a Viable Adjunctive Treatment for Subs... | NCT03540745

Studies
Nexalin Therapy as a Viable Adjunctive Treatment for Substance Use Disorders

NCT03540745

Sponsor

University of Arizona

Status

Active, not recruiting

Last Update Posted

Oct 11, 2018Actual

Enrollment

14Actual

Phase

Not Applicable

Conditions

Depression
Anxiety
Insomnia
Substance Abuse

Interventions

TES Treatment
TES-SHAM Treatment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 11, 2018Actual

Primary Completion Date

Apr 2019Estimated

Completion Date

Nov 2019Estimated

First Submitted Date

Mar 12, 2018

First Submission Date that Met QC Criteria

May 29, 2018

First Posted Date

May 30, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2018

Last Update Posted Date

Oct 11, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michael A. Grandner, Assistant Professor of Psychiatry, Psychology, and Medicine Director, Sleep & Health Research Program, University of ArizonaPrincipal Investigator

Lead Sponsor

University of ArizonaOTHER

Collaborators

Name	Class
Carrier Clinic	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this research study is to determine whether Nexalin Trans-cranial Electrical Stimulation (TES) is a viable adjunctive treatment of substance use treatments.

Detailed Description

A Randomized Controlled Trial with block randomization. Inpatient subjects actively seeking substance abuse treatment at the Carrier Clinic who are diagnosed with a substance use disorder, including alcohol use disorder, tobacco use disorder, polysubstance use disorder, or other substance use disorder.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TES Treatment	Experimental	Where subject is randomized to TES.	Device: TES Treatment
TES-SHAM Treatment	Placebo Comparator	Where subject is randomized to a SHAM condition	Device: TES-SHAM Treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TES Treatment	Device	Device: Nexalin Based Trans-Cranial Electrical Stimulation The Nexalin device, FDA clearance (501K=K024377, Classification: Stimulator, Cranial Electrotherapy: CFR 882. 5800: U.S. Patent #6904322B2), produces a square waveform that provides trans-cranial electrical stimulation to the brain delivered at a frequency of 77.5 Hz at 0 to 4 mA peak current. Other Name: TES

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment response	Reduction in depressive symptoms as a result of Nexalin vs Sham	5-8 Days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be able to provide informed consent, assessed by the study clinician
Be able to speak, read and write fluently in English, assessed by the study clinician
Be committed to completion of the study. The subject will need to attest to availability for 10 to 15 treatments over a 5 to 8 day period for the treatment protocol.
Be adults over age 18 and under age 65
Be actively receiving substance use treatment for a substance use disorder

Exclusion Criteria:

Pregnant or at risk of becoming pregnant
Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, might confound the interpretation of the study results, or put the person at undue risk

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael R Grandner, PhD	University of Arizona	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Carrier Clinic		Belle Mead	New Jersey	08502	United States

Submission Tracking

Estimated Results First Submitted Date

Feb 1, 2022

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 1, 2022			Feb 23, 2022	3
Feb 1, 2024

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D001008	Anxiety Disorders
D007319	Sleep Initiation and Maintenance Disorders
D019966	Substance-Related Disorders

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D001523	Mental Disorders
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided