Substance Use Disorders
Conditions
Keywords
tACS, Brain Stimulation, Transcranial Alternating Current Stimulation, Substance Use
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.
Interventions
DEVICETranscranial Alternating Current Stimulation at 10 Hz
Non-invasive, safe transcranial alternating current stimulation administered at 10 Hz to target alpha oscillatory activity
DEVICETranscranial Alternating Current Stimulation at 40 Hz
Non-invasive, safe transcranial alternating current stimulation administered at 40 Hz to target gamma oscillatory activity
DEVICEActive sham transcranial alternating current stimulation
Active sham (placebo)
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Sham Stimulation (Session 1 and Session 2) Active sham transcranial alternating current stimulation: Active sham (placebo) | 13 |
| Active Sham (Session 1) and tACS at 10 Hz (Session 2) Active Sham during Session 1 and Transcranial Alternating Current Stimulation at 10 Hz during Session 2
Transcranial Alternating Current Stimulation at 10 Hz: Non-invasive, safe transcranial alternating current stimulation administered at 10 Hz to target alpha oscillatory activity | 12 |
| Active Sham (Session 1) and tACS at 40 Hz (Session 2) Active Sham during Session 1 and Transcranial Alternating Current Stimulation at 40 Hz during Session 2
Transcranial Alternating Current Stimulation at 40 Hz: Non-invasive, safe transcranial alternating current stimulation administered at 40 Hz to target gamma oscillatory activity | 13 |
| Total | 38 |
Baseline characteristics
| Characteristic | Active Sham Stimulation (Session 1 and Session 2) | Total | Active Sham (Session 1) and tACS at 40 Hz (Session 2) | Active Sham (Session 1) and tACS at 10 Hz (Session 2) |
|---|---|---|---|---|
| Age, Continuous | 43.5 years STANDARD_DEVIATION 6.5 | 43.2 years STANDARD_DEVIATION 7.7 | 42.9 years STANDARD_DEVIATION 7.8 | 43.3 years STANDARD_DEVIATION 9.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 11 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 5 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 22 Participants | 7 Participants | 8 Participants |
| Region of Enrollment United States | 13 Participants | 38 Participants | 13 Participants | 12 Participants |
| Sex: Female, Male Female | 5 Participants | 13 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 8 Participants | 25 Participants | 8 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 12 | 0 / 13 |
| other Total, other adverse events | 0 / 13 | 0 / 12 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 12 | 0 / 13 |
Outcome results
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).
Time frame: From Session 1 to Session 2, up to 6 days
Population: 3 participants did not have data due to impedance issues, behavioral noncompliance, and technology error
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Sham Stimulation (Session 1 and Session 2) | Change in Distress Tolerance (Mean Latency to Quit the PASAT-C) | 11.2 minutes | Standard Deviation 5.5 |
| Active Sham (Session 1) and tACS at 10 Hz (Session 2) | Change in Distress Tolerance (Mean Latency to Quit the PASAT-C) | 9.8 minutes | Standard Deviation 6.4 |
| Active Sham (Session 1) and tACS at 40 Hz (Session 2) | Change in Distress Tolerance (Mean Latency to Quit the PASAT-C) | 9.4 minutes | Standard Deviation 6.2 |
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.
Time frame: From Session 1 to Session 2, up to 6 days
Population: 3 participants did not have data due to impedance issues, behavioral noncompliance, and technology error
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Sham Stimulation (Session 1 and Session 2) | Change in Inhibitory Control (Mean D-prime on the Go/No-Go) | -0.6 z-score | Standard Deviation 2 |
| Active Sham (Session 1) and tACS at 10 Hz (Session 2) | Change in Inhibitory Control (Mean D-prime on the Go/No-Go) | 0.9 z-score | Standard Deviation 1.7 |
| Active Sham (Session 1) and tACS at 40 Hz (Session 2) | Change in Inhibitory Control (Mean D-prime on the Go/No-Go) | -0.3 z-score | Standard Deviation 1.9 |