Non-Invasive Brain Stimulation and Substance Use

Substance Use Disorders Clinical Trial

Official title:

Non-Invasive Brain Stimulation and Substance Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03122587
• Other study ID #: 16-2342
• Status: Completed
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: July 2019
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

Device:
• Transcranial Alternating Current Stimulation at 10 Hz
Non-invasive, safe transcranial alternating current stimulation administered at 10 Hz to target alpha oscillatory activity
• Transcranial Alternating Current Stimulation at 40 Hz
Non-invasive, safe transcranial alternating current stimulation administered at 40 Hz to target gamma oscillatory activity
• Active sham transcranial alternating current stimulation
Active sham (placebo)

Locations

Country	Name	City	State
United States	Southlight Healthcare	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	From Session 1 to Session 2, up to 6 days
Primary	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.	From Session 1 to Session 2, up to 6 days