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Completed

NCT Number: NCT03122587

Non-Invasive Brain Stimulation and Substance Use

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.

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Key information

Conditions

Substance Use Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southlight Healthcare

Raleigh, North Carolina, 27604, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Alternating Current Stimulation at 10 Hz

Device

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

Other names: tACS at 10 Hz

Transcranial Alternating Current Stimulation at 40 Hz

Device

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

Other names: tACS at 40 Hz

Active sham transcranial alternating current stimulation

Device

Active sham (placebo)

Other names: Active sham

Primary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 21, 2017
Registry last updated
Mar 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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