Substance Use DisordersNCT03122587
Non-Invasive Brain Stimulation and Substance Use
A study testing Transcranial Alternating Current Stimulation at 10 Hz and Transcranial Alternating Current Stimulation at 40 Hz in people with Substance Use Disorders, run by University of North Carolina, Chapel Hill at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Transcranial Alternating Current Stimulation at 10 Hz and Transcranial Alternating Current Stimulation at 40 Hz
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2017to 1 Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Southlight Healthcare
Raleigh, North Carolina, 27604
About this study
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.
Read the 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.
- Conditions
- Substance Use Disorders
- Being tested
- Transcranial Alternating Current Stimulation at 10 Hz, Transcranial Alternating Current Stimulation at 40 Hz, Active sham transcranial alternating current stimulation
- Keywords
- tACS, Brain Stimulation, Transcranial Alternating Current Stimulation, Substance Use
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Alternating Current Stimulation at 10 HzDevice
Also called tACS 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 HzDevice
Also called tACS at 40 Hz
Non-invasive, safe transcranial alternating current stimulation administered at 40 Hz to target gamma oscillatory activity
Active sham transcranial alternating current stimulationDevice
Also called Active sham
Active sham (placebo)
| Study group | Role | What they receive |
|---|---|---|
| Active Sham (Session 1 and Session 2) | Sham comparator | Active sham transcranial alternating current stimulation (tACS) during Session 1 and Session 2 Receives: Device: Active sham transcranial alternating current stimulation |
| 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 Receives: Device: Transcranial Alternating Current Stimulation at 10 Hz |
| 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 Receives: Device: Transcranial Alternating Current Stimulation at 40 Hz |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: From Session 1 to Session 2, up to 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start15 May 2017
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stacey B Daughters, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122587
- Sponsor's protocol ID
- 16-2342
- Status last verified
- Jul 2019
- First submitted
- 4 Apr 2017
- Last updated
- 6 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Brain Stimulation and Substance Use
- ClinicalTrials.gov ID
- NCT03122587
- Acronym / sponsor ID
- 16-2342
- Conditions
- Substance Use Disorders
- Keywords
- tACS, Brain Stimulation, Transcranial Alternating Current Stimulation, Substance Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Posted 6 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Sham (Session 1 and Session 2) | Sham comparator | Device: Active sham transcranial alternating current stimulationActive sham transcranial alternating current stimulation (tACS) during Session 1 and Session 2 |
| Active Sham (Session 1) and tACS at 10 Hz (Session 2) | Experimental | Device: Transcranial Alternating Current Stimulation at 10 HzActive 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 | Device: Transcranial Alternating Current Stimulation at 40 HzActive sham transcranial alternating current stimulation (tACS) during Session 1 and Transcranial Alternating Current Stimulation at 40 Hz during Session 2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Alternating Current Stimulation at 10 HzAlso: tACS at 10 HzNon-invasive, safe transcranial alternating current stimulation administered at 10 Hz to target alpha oscillatory activity | Device | Active Sham (Session 1) and tACS at 10 Hz (Session 2) |
| Transcranial Alternating Current Stimulation at 40 HzAlso: tACS at 40 HzNon-invasive, safe transcranial alternating current stimulation administered at 40 Hz to target gamma oscillatory activity | Device | Active Sham (Session 1) and tACS at 40 Hz (Session 2) |
| Active sham transcranial alternating current stimulationAlso: Active shamActive sham (placebo) | Device | Active Sham (Session 1 and Session 2) |
Primary outcome
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).
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacey B Daughters, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Alternating Current Stimulation at 10 Hz and Transcranial Alternating Current Stimulation at 40 Hz in people with Substance Use Disorders, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Distress Tolerance (Mean Latency to Quit the PASAT-C) (time frame: From Session 1 to Session 2, up to 6 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.