Anxiety, Depression, Insomnia, Substance Abuse
Conditions
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.
Interventions
DEVICETES 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
DEVICETES-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
Sponsors
Carrier Clinic
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All participants and investigators are blind to condition
Intervention model description
Randomized Controlled Trial with block randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment response | 5-8 Days | Reduction in depressive symptoms as a result of Nexalin vs Sham |
Countries
United States
Outcome results
None listed