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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Sham (Session 1 and Session 2) | Sham Comparator | Active sham transcranial alternating current stimulation (tACS) during Session 1 and Session 2 |
|
| Active Sham (Session 1) and tACS at 10 Hz (Session 2) | Experimental | 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) | Experimental | Active sham transcranial alternating current stimulation (tACS) during Session 1 and Transcranial Alternating Current Stimulation at 40 Hz during Session 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Alternating Current Stimulation at 10 Hz | Device | Non-invasive, safe transcranial alternating current stimulation administered at 10 Hz to target alpha oscillatory activity |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stacey B Daughters, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southlight Healthcare | Raleigh | North Carolina | 27604 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Sham Stimulation (Session 1 and Session 2) | Active sham transcranial alternating current stimulation: Active sham (placebo) |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Sham Stimulation (Session 1 and Session 2) | Active sham transcranial alternating current stimulation: Active sham (placebo) |
| BG001 | Active Sham (Session 1) and tACS at 10 Hz (Session 2) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 3 participants did not have data due to impedance issues, behavioral noncompliance, and technology error | Posted | Mean | Standard Deviation | minutes | From Session 1 to Session 2, up to 6 days |
|
From Session 1 to Session 2, up to 6 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Sham Stimulation | Active sham transcranial alternating current stimulation: Active sham (placebo) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stacey Daughters, PhD | University of North Carolina at Chapel Hill | 9199629924 | daughter@unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 16, 2016 | Jan 24, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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|
| Transcranial Alternating Current Stimulation at 40 Hz | Device | Non-invasive, safe transcranial alternating current stimulation administered at 40 Hz to target gamma oscillatory activity |
|
|
| Active sham transcranial alternating current stimulation | Device | Active sham (placebo) |
|
|
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
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG000 |
| Active Sham Stimulation (Session 1 and Session 2) |
Active sham transcranial alternating current stimulation: Active sham (placebo) |
| OG001 | 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 |
| OG002 | 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 |
|
|
| 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. | 3 participants did not have data due to impedance issues, behavioral noncompliance, and technology error | Posted | Mean | Standard Deviation | z-score | From Session 1 to Session 2, up to 6 days |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | 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 | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | 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 | 0 | 13 | 0 | 13 | 0 | 13 |
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