Nexalin Therapy as a Viable Adjunctive Treatment for Substance Use Disorders

Study Overview
=================
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.

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

Conditions
-----------------
Depression, Anxiety, Insomnia, Substance Abuse

Intervention / Treatment
-----------------
* Device: TES Treatment
* Device: TES-SHAM Treatment


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial with block randomization
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TES Treatment<br>Where subject is randomized to TES. | Device: TES Treatment<br>* 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<br>|
| Placebo Comparator: TES-SHAM Treatment<br>Where subject is randomized to a SHAM condition | Device: TES-SHAM Treatment<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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