Non-Invasive Brain Stimulation and Substance Use
1 other identifier
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2017
CompletedFirst Posted
Study publicly available on registry
April 21, 2017
CompletedStudy Start
First participant enrolled
May 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedResults Posted
Study results publicly available
March 6, 2020
CompletedMarch 6, 2020
July 1, 2019
1.7 years
April 4, 2017
January 24, 2020
February 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
Active Sham (Session 1 and Session 2)
SHAM COMPARATORActive sham transcranial alternating current stimulation (tACS) during Session 1 and Session 2
Active Sham (Session 1) and tACS at 10 Hz (Session 2)
EXPERIMENTALActive 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)
EXPERIMENTALActive sham transcranial alternating current stimulation (tACS) during Session 1 and Transcranial Alternating Current Stimulation at 40 Hz during Session 2
Interventions
Non-invasive, safe transcranial alternating current stimulation administered at 10 Hz to target alpha oscillatory activity
Non-invasive, safe transcranial alternating current stimulation administered at 40 Hz to target gamma oscillatory activity
Active sham (placebo)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southlight Healthcare
Raleigh, North Carolina, 27604, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stacey Daughters, PhD
- Organization
- University of North Carolina at Chapel Hill
Study Officials
- PRINCIPAL INVESTIGATOR
Stacey B Daughters, PhD
University of North Carolina, Chapel Hill
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2017
First Posted
April 21, 2017
Study Start
May 15, 2017
Primary Completion
February 1, 2019
Study Completion
February 1, 2019
Last Updated
March 6, 2020
Results First Posted
March 6, 2020
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share