Nexalin Therapy as a Viable Adjunctive Treatment for Substance Use Disorders

N/AActive Not RecruitingNCT03540745

University of Arizona14 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Depression Anxiety Insomnia Substance Abuse

Interventions

TES TreatmentDEVICE

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

TES-SHAM TreatmentDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Carrier Clinic

Belle Mead, New Jersey, United States

Outcomes

Primary Outcomes

Treatment response

Reduction in depressive symptoms as a result of Nexalin vs Sham

Time frame: 5-8 Days

Data from ClinicalTrials.gov

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