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Nexalin Therapy as a Viable Adjunctive Treatment for Substance Use Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03540745
Recruitment Status : Active, not recruiting
First Posted : May 30, 2018
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Carrier Clinic
Information provided by (Responsible Party):
Michael A. Grandner, University of Arizona

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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Insomnia Substance Abuse Device: TES Treatment Device: TES-SHAM Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial with block randomization
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: All participants and investigators are blind to condition
Primary Purpose: Treatment
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
Actual Study Start Date : June 11, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TES Treatment
Where subject is randomized to TES.
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

Placebo Comparator: TES-SHAM Treatment
Where subject is randomized to a SHAM condition
Device: 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




Primary Outcome Measures :
  1. Treatment response [ Time Frame: 5-8 Days ]
    Reduction in depressive symptoms as a result of Nexalin vs Sham



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03540745


Locations
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United States, New Jersey
Carrier Clinic
Belle Mead, New Jersey, United States, 08502
Sponsors and Collaborators
University of Arizona
Carrier Clinic
Investigators
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Principal Investigator: Michael R Grandner, PhD University of Arizona

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Responsible Party: Michael A. Grandner, Assistant Professor of Psychiatry, Psychology, and Medicine Director, Sleep & Health Research Program, University of Arizona
ClinicalTrials.gov Identifier: NCT03540745     History of Changes
Other Study ID Numbers: 1712118546
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders