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Non-Invasive Brain Stimulation and Substance Use

Primary Purpose

Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Alternating Current Stimulation at 10 Hz
Transcranial Alternating Current Stimulation at 40 Hz
Active sham transcranial alternating current stimulation
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Substance Use Disorders focused on measuring tACS, Brain Stimulation, Transcranial Alternating Current Stimulation, Substance Use

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southlight Healthcare

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

Active Sham (Session 1 and Session 2)

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

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

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in Distress Tolerance (Mean Latency to Quit the PASAT-C)
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).
Change in Inhibitory Control (Mean D-prime on the Go/No-Go)
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.

Secondary Outcome Measures

Full Information

First Posted
April 4, 2017
Last Updated
February 20, 2020
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT03122587
Brief Title
Non-Invasive Brain Stimulation and Substance Use
Official Title
Non-Invasive Brain Stimulation and Substance Use
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
tACS, Brain Stimulation, Transcranial Alternating Current Stimulation, Substance Use

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Sham (Session 1 and Session 2)
Arm Type
Sham Comparator
Arm Description
Active sham transcranial alternating current stimulation (tACS) during Session 1 and Session 2
Arm Title
Active Sham (Session 1) and tACS at 10 Hz (Session 2)
Arm Type
Experimental
Arm Description
Active sham transcranial alternating current stimulation (tACS) during Session 1 and Transcranial Alternating Current Stimulation at 10 Hz during Session 2
Arm Title
Active Sham (Session 1) and tACS at 40 Hz (Session 2)
Arm Type
Experimental
Arm Description
Active sham transcranial alternating current stimulation (tACS) during Session 1 and Transcranial Alternating Current Stimulation at 40 Hz during Session 2
Intervention Type
Device
Intervention Name(s)
Transcranial Alternating Current Stimulation at 10 Hz
Other Intervention Name(s)
tACS at 10 Hz
Intervention Description
Non-invasive, safe transcranial alternating current stimulation administered at 10 Hz to target alpha oscillatory activity
Intervention Type
Device
Intervention Name(s)
Transcranial Alternating Current Stimulation at 40 Hz
Other Intervention Name(s)
tACS at 40 Hz
Intervention Description
Non-invasive, safe transcranial alternating current stimulation administered at 40 Hz to target gamma oscillatory activity
Intervention Type
Device
Intervention Name(s)
Active sham transcranial alternating current stimulation
Other Intervention Name(s)
Active sham
Intervention Description
Active sham (placebo)
Primary Outcome Measure Information:
Title
Change in Distress Tolerance (Mean Latency to Quit the PASAT-C)
Description
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).
Time Frame
From Session 1 to Session 2, up to 6 days
Title
Change in Inhibitory Control (Mean D-prime on the Go/No-Go)
Description
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.
Time Frame
From Session 1 to Session 2, up to 6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacey B Daughters, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southlight Healthcare
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27604
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Non-Invasive Brain Stimulation and Substance Use

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