Non-Invasive Brain Stimulation and Substance Use

February 20, 2020 updated by: University of North Carolina, Chapel Hill
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Raleigh, North Carolina, United States, 27604
        • Southlight Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Active Sham (Session 1 and Session 2)
Active sham transcranial alternating current stimulation (tACS) during Session 1 and Session 2
Device: Active sham transcranial alternating current stimulation
Active sham (placebo)
Other Names:
  • Active sham
Experimental: 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
Device: Transcranial Alternating Current Stimulation at 10 Hz
Non-invasive, safe transcranial alternating current stimulation administered at 10 Hz to target alpha oscillatory activity
Other Names:
  • tACS at 10 Hz
Experimental: 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
Device: Transcranial Alternating Current Stimulation at 40 Hz
Non-invasive, safe transcranial alternating current stimulation administered at 40 Hz to target gamma oscillatory activity
Other Names:
  • tACS at 40 Hz

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Distress Tolerance (Mean Latency to Quit the PASAT-C)
Time Frame: From Session 1 to Session 2, up to 6 days
The Computerized Paced Auditory Serial Addition Task (PASAT-C) is a psychological distress-inducing task. Numbers are presented sequentially on a computer screen and participants are asked to add the currently presented number to the previously presented number before the next number is presented. Participants select the answer using a computer mouse on a number pad displayed on the computer screen below the presented numbers. The speed of the number presentations is individually titrated in order to account for some individual differences in cognitive capacity, but not to secure equal performance among individuals. Incorrect or delayed responses are met with an aversive explosion sound. Distress tolerance is the latency to task termination (i.e., time until quit in minutes).
From Session 1 to Session 2, up to 6 days
Change in Inhibitory Control (Mean D-prime on the Go/No-Go)
Time Frame: From Session 1 to Session 2, up to 6 days
During the computerized Go/No-Go task, participants view a serial stream of pictures and are instructed to continuously press a button on the computer keyboard, but inhibit responses when stimuli are presented consecutively. Inhibitory control will be calculated as d-prime [z(hit rate) - z(false alarm rate)]. Each z-score of 0 is equal to the mean of the reference population, with a standard deviation of 1. Positive d-prime values indicate more inhibitory control, and negative values indicate less inhibitory control.
From Session 1 to Session 2, up to 6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Stacey B Daughters, PhD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2017

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

April 4, 2017

First Submitted That Met QC Criteria

April 17, 2017

First Posted (Actual)

April 21, 2017

Study Record Updates

Last Update Posted (Actual)

March 6, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-2342

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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