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Trial record 2 of 163 for:    Recruiting, Not yet recruiting Studies | substance use

Non-Invasive Brain Stimulation and Substance Use

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ClinicalTrials.gov Identifier: NCT03122587
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
The will investigate the feasibility and effectiveness of non-invasive transcranial alternating current stimulation (tACS) among treatment seeking substance users.

Condition or disease Intervention/treatment Phase
Substance Use Disorders Device: Transcranial Alternating Current Stimulation at 10 Hz Device: Transcranial Alternating Current Stimulation at 40 Hz Device: Active sham transcranial alternating current stimulation Not Applicable

Detailed Description:
Distress tolerance, defined as the ability to persist in goal directed behavior while experiencing affective distress (e.g., anxiety, stress, irritability) is 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, among substance users may be malleable, providing a promising intervention. More specifically, modulating neural oscillations with non-invasive, safe brain stimulation by targeting regions such as the DLPFC may provide an avenue to improve distress tolerance among substance users. 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 processes, such as distress tolerance. Despite its potential, limited research to date has examined the feasibility and optimization of tACS as a treatment methodology to facilitate cognitive function among individuals with substance use disorder. Thus, this study will investigate the effects of tACS on distress tolerance among treatment-seeking individuals with substance use disorder.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Non-Invasive Brain Stimulation and Substance Use
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Sham Comparator: Active Sham Stimulation
Active sham transcranial alternating current stimulation (tACS)
Device: Active sham transcranial alternating current stimulation
Active sham (placebo)
Other Name: Active sham

Experimental: tACS at 10 Hz
Transcranial Alternating Current Stimulation at 10 Hz
Device: Transcranial Alternating Current Stimulation at 10 Hz
Non-invasive, safe transcranial alternating current stimulation administered at 10 Hz to target alpha oscillatory activity
Other Name: tACS at 10 Hz

Experimental: tACS at 40 Hz
Transcranial Alternating Current Stimulation at 40 Hz
Device: Transcranial Alternating Current Stimulation at 40 Hz
Non-invasive, safe transcranial alternating current stimulation administered at 40 Hz to target gamma oscillatory activity
Other Name: tACS at 40 Hz




Primary Outcome Measures :
  1. Change in task performance on the computerized PASAT-C task [ Time Frame: Session 1 and Session 2 (approximately 3-5 days between Sessions 1 and 2) ]
    The computerized Paced Auditory Serial Addition Task (PASAT-C; Lejuez et al., 2003) 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. Accuracy (% correct and % omitted), mean inter-stimulus interval (ISI = ISImean - ISIbaseline), and latency to task termination (i.e., time until quit in seconds and minutes) will be recorded.


Secondary Outcome Measures :
  1. Change in task performance on the computerized Go/No-Go task [ Time Frame: Session 1 and Session 2 (approximately 3-5 days between Sessions 1 and 2) ]
    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. Accuracy (% correct non-occurrences/omissions) and mean response time will be recorded. This task will be used as a low demand cognitive task.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122587


Contacts
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Contact: Stacey B Daughters, PhD 9199629924 daughter@unc.edu

Locations
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United States, North Carolina
Southlight Healthcare Recruiting
Raleigh, North Carolina, United States, 27604
Contact: Stacey Daughters       daughter@unc.edu   
Principal Investigator: Stacey B Daughters, Ph.D.         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Stacey B Daughters, PhD University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03122587     History of Changes
Other Study ID Numbers: 16-2342
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by University of North Carolina, Chapel Hill:
tACS
Brain Stimulation
Transcranial Alternating Current Stimulation
Substance Use

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dihydrotachysterol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents