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Nexalin Therapy as a Viable Adjunctive Treatment for Substance Use Disorders

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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

Tracking Information
First Submitted Date  ICMJE March 12, 2018
First Posted Date  ICMJE May 30, 2018
Last Update Posted Date October 11, 2018
Actual Study Start Date  ICMJE June 11, 2018
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2018)
Treatment response [ Time Frame: 5-8 Days ]
Reduction in depressive symptoms as a result of Nexalin vs Sham
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03540745 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nexalin Therapy as a Viable Adjunctive Treatment for Substance Use Disorders
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Depression
  • Anxiety
  • Insomnia
  • Substance Abuse
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: TES Treatment
    Where subject is randomized to TES.
    Intervention: Device: TES Treatment
  • Placebo Comparator: TES-SHAM Treatment
    Where subject is randomized to a SHAM condition
    Intervention: Device: TES-SHAM Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 9, 2018)
14
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2018)
150
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03540745
Other Study ID Numbers  ICMJE 1712118546
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael A. Grandner, University of Arizona
Study Sponsor  ICMJE University of Arizona
Collaborators  ICMJE Carrier Clinic
Investigators  ICMJE
Principal Investigator: Michael R Grandner, PhD University of Arizona
PRS Account University of Arizona
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP