Non-Invasive Brain Stimulation and Substance Use

NCT ID: NCT03122587

Last Updated: 2020-03-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-15

Study Completion Date

2019-02-01

Brief Summary

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The will investigate the feasibility and effectiveness and initial efficacy of non-invasive transcranial alternating current stimulation (tACS) on distress tolerance and inhibitory control among treatment seeking substance users.

Detailed Description

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Disruptions in inhibitory control (IC) and distress tolerance (DT) are implicated in the development and maintenance of substance use disorders. Findings suggest that differential DLPFC engagement during affective and cognitive processing, and in particular, distress tolerance, in substance use disorder may be malleable, providing a promising intervention. Modulating neural oscillations with non-invasive, safe brain stimulation by targeting regions such as the DLPFC may provide an avenue to improve distress tolerance and inhibitory control in SUD. Transcranial alternating current stimulation (tACS) may be a particularly promising approach as it is a safe and non-invasive method of electric stimulation that has the potential to effectively modulate neural network and circuit dynamics, more closely aligning with a network-based conceptualization of affective and cognitive processesThis study will test the effects of tACS on distress tolerance and inhibitory control among treatment-seeking adults with substance use disorder.

Conditions

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Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active Sham (Session 1 and Session 2)

Active sham transcranial alternating current stimulation (tACS) during Session 1 and Session 2

Group Type SHAM_COMPARATOR

Active sham transcranial alternating current stimulation

Intervention Type DEVICE

Active sham (placebo)

Active Sham (Session 1) and tACS at 10 Hz (Session 2)

Active sham transcranial alternating current stimulation (tACS) during Session 1 and Transcranial Alternating Current Stimulation at 10 Hz during Session 2

Group Type EXPERIMENTAL

Transcranial Alternating Current Stimulation at 10 Hz

Intervention Type DEVICE

Non-invasive, safe transcranial alternating current stimulation administered at 10 Hz to target alpha oscillatory activity

Active Sham (Session 1) and tACS at 40 Hz (Session 2)

Active sham transcranial alternating current stimulation (tACS) during Session 1 and Transcranial Alternating Current Stimulation at 40 Hz during Session 2

Group Type EXPERIMENTAL

Transcranial Alternating Current Stimulation at 40 Hz

Intervention Type DEVICE

Non-invasive, safe transcranial alternating current stimulation administered at 40 Hz to target gamma oscillatory activity

Interventions

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Transcranial Alternating Current Stimulation at 10 Hz

Non-invasive, safe transcranial alternating current stimulation administered at 10 Hz to target alpha oscillatory activity

Intervention Type DEVICE

Transcranial Alternating Current Stimulation at 40 Hz

Non-invasive, safe transcranial alternating current stimulation administered at 40 Hz to target gamma oscillatory activity

Intervention Type DEVICE

Active sham transcranial alternating current stimulation

Active sham (placebo)

Intervention Type DEVICE

Other Intervention Names

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tACS at 10 Hz tACS at 40 Hz Active sham

Eligibility Criteria

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Inclusion Criteria

* Current Diagnostic and Statistical Manual of Mental Disorders (DSM-V) Substance Use Disorder
* Current smoker
* Abstinent from all substances (except nicotine) for at least the past 2 weeks

Exclusion Criteria

* Current use of antiepileptic drugs and/or benzodiazepines
* Less than 6 months since an electroconvulsive therapy (ECT) session
* Current DSM-V Psychotic Disorder
* Pregnancy and/or nursing
* Ongoing or history of traumatic brain injury (TBI), reoccurring seizures, stroke, or brain tumors
* Medical or neurological illness
* Brain devices and/or implants
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stacey B Daughters, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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Southlight Healthcare

Raleigh, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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16-2342

Identifier Type: -

Identifier Source: org_study_id

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