Nexalin Therapy as a Viable Adjunctive Treatment for Substance Use Disorders

Not Applicable

Active, not recruiting

• Conditions: Anxiety; Substance Abuse; Depression; Insomnia
• Interventions: Device: TES Treatment; Device: TES-SHAM Treatment

• Registration Number: NCT03540745
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-05-29
• Study First Posted: 2018-05-30
• Study Start: 2018-06-11
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-09
• Last Update Posted: 2018-10-11
• Primary Completion: 2019-04
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TES Treatment	TES Treatment	Where subject is randomized to TES.
TES-SHAM Treatment	TES-SHAM Treatment	Where subject is randomized to a SHAM condition

Primary Outcome Measures

Name	Time	Method
Treatment response	5-8 Days	Reduction in depressive symptoms as a result of Nexalin vs Sham

Trial Locations

Locations (1)

Carrier Clinic; 🇺🇸 Belle Mead, New Jersey, United States