Nexalin Therapy as a Viable Adjunctive Treatment for Substance Use Disorders

NCT03540745 | Active Not Recruiting FDA Device

• 1 other identifier: 1712118546
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety; Insomnia; Substance Abuse

Outcome Measures

Primary Outcomes (1)

• Treatment response

  Reduction in depressive symptoms as a result of Nexalin vs Sham

  5-8 Days

Study Arms (2)

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

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 Treatment

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

TES-SHAM Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• Carrier Clinic: collaborator

Study Sites (1)

Carrier Clinic

Belle Mead, New Jersey, 08502, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Sleep Initiation and Maintenance Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Chemically-Induced Disorders

Study Officials

• Michael R Grandner, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants and investigators are blind to condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry, Psychology, and Medicine Director, Sleep & Health Research Program

Model Details: Randomized Controlled Trial with block randomization

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: May 30, 2018
• Study Start: June 11, 2018
• Primary Completion: April 1, 2019
• Study Completion: November 1, 2019
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

US (1)