Nexalin Therapy as a Viable Adjunctive Treatment for Substance Use Disorders

Depression Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03540745
• Other study ID #: 1712118546
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 11, 2018
• Est. completion date: November 2019

Study information

• Verified date: October 2018
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: November 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Insomnia
• Substance Abuse
• Substance-Related Disorders

Intervention

Device:
• TES Treatment
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: 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

Locations

Country	Name	City	State
United States	Carrier Clinic	Belle Mead	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	Carrier Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment response	Reduction in depressive symptoms as a result of Nexalin vs Sham	5-8 Days