Non-Invasive Brain Stimulation and Substance Use

Not Applicable

Completed

Conditions: Substance Use Disorders

Interventions: Device: Active sham transcranial alternating current stimulation
Device: Transcranial Alternating Current Stimulation at 10 Hz
Device: Transcranial Alternating Current Stimulation at 40 Hz

Registration Number: NCT03122587

Lead Sponsor: University of North Carolina, Chapel Hill

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 38

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Sham (Session 1 and Session 2)	Active sham transcranial alternating current stimulation	Active sham transcranial alternating current stimulation (tACS) during Session 1 and Session 2
Active Sham (Session 1) and tACS at 10 Hz (Session 2)	Transcranial Alternating Current Stimulation at 10 Hz	Active sham transcranial alternating current stimulation (tACS) during Session 1 and Transcranial Alternating Current Stimulation at 10 Hz during Session 2
Active Sham (Session 1) and tACS at 40 Hz (Session 2)	Transcranial Alternating Current Stimulation at 40 Hz	Active sham transcranial alternating current stimulation (tACS) during Session 1 and Transcranial Alternating Current Stimulation at 40 Hz during Session 2

Primary Outcome Measures

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

Secondary Outcome Measures