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Nexalin Therapy as a Viable Adjunctive Treatment for Substance Use Disorders

Primary Purpose

Depression, Anxiety, Insomnia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TES Treatment
TES-SHAM Treatment
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Be able to provide informed consent, assessed by the study clinician
  2. Be able to speak, read and write fluently in English, assessed by the study clinician
  3. 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.
  4. Be adults over age 18 and under age 65
  5. Be actively receiving substance use treatment for a substance use disorder

Exclusion Criteria:

  1. Pregnant or at risk of becoming pregnant
  2. 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

Sites / Locations

  • Carrier Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TES Treatment

TES-SHAM Treatment

Arm Description

Where subject is randomized to TES.

Where subject is randomized to a SHAM condition

Outcomes

Primary Outcome Measures

Treatment response
Reduction in depressive symptoms as a result of Nexalin vs Sham

Secondary Outcome Measures

Full Information

First Posted
March 12, 2018
Last Updated
October 9, 2018
Sponsor
University of Arizona
Collaborators
Carrier Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03540745
Brief Title
Nexalin Therapy as a Viable Adjunctive Treatment for Substance Use Disorders
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Nexalin Electrical Brain Stimulation as an Adjunctive Therapy for Substance Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
Collaborators
Carrier Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Insomnia, Substance Abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial with block randomization
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All participants and investigators are blind to condition
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TES Treatment
Arm Type
Experimental
Arm Description
Where subject is randomized to TES.
Arm Title
TES-SHAM Treatment
Arm Type
Placebo Comparator
Arm Description
Where subject is randomized to a SHAM condition
Intervention Type
Device
Intervention Name(s)
TES Treatment
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
TES-SHAM Treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
Treatment response
Description
Reduction in depressive symptoms as a result of Nexalin vs Sham
Time Frame
5-8 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael R Grandner, PhD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carrier Clinic
City
Belle Mead
State/Province
New Jersey
ZIP/Postal Code
08502
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Nexalin Therapy as a Viable Adjunctive Treatment for Substance Use Disorders

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