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Active, Not Recruiting

NCT Number: NCT03540745

Nexalin Therapy as a Viable Adjunctive Treatment for Substance Use Disorders

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Chemically-Induced Disorders Dyssomnias Insomnia Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Substance Abuse Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carrier Clinic

Belle Mead, New Jersey, 08502, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

TES-SHAM 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

Primary outcomes

  1. Treatment response

    Time frame: 5-8 Days

    Reduction in depressive symptoms as a result of Nexalin vs Sham

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • Carrier Clinic

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 30, 2018
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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