Nexalin Therapy as a Viable Adjunctive Treatment for Substance Use Disorders

University of Arizona

Status: Active, not recruiting

Conditions: Insomnia; Depression; Substance Abuse; Anxiety

Treatments: Device: TES Treatment; Device: TES-SHAM Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03540745

1712118546

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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14 participants in 2 patient groups, including a placebo group

TES Treatment

Experimental group

Description:

Where subject is randomized to TES.

Treatment:

Device: TES Treatment

TES-SHAM Treatment

Placebo Comparator group

Description:

Where subject is randomized to a SHAM condition

Treatment:

Device: TES-SHAM Treatment