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Neuromodulation and Cognitive Training for Substance Use Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04426214
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : July 18, 2022
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
The relapsing nature of substance use disorder is a major obstacle to successful treatment. About 70% of those entering treatment will relapse within one year. To improve treatment outcome, new interventions targeting the underlying brain biomarkers of relapse vulnerability hold significant promise in reducing this critical public health problem. This study is testing a new intervention, namely tDCS-Augmented Cognitive Training, to engage these brain biomarkers to improve cognition and improve treatment outcomes.

Condition or disease Intervention/treatment Phase
Stimulant Use Alcohol Use Disorder Device: tDCS Behavioral: Cognitive Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neuromodulation and Cognitive Training for Substance Use Disorders
Actual Study Start Date : July 16, 2021
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active tDCS Device: tDCS
We will apply tDCS in combination with cognitive training. All participants receive cognitive training, and will be randomized to receive either active or sham tDCS

Behavioral: Cognitive Training
cognitive training on computer

Placebo Comparator: Sham tDCS Behavioral: Cognitive Training
cognitive training on computer




Primary Outcome Measures :
  1. Percent of participants with clean drug screens [ Time Frame: 2 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Abstinent from any substance or alcohol use (excluding caffeine or nicotine) for a minimum of 3 weeks at study enrollment
  • Has the intention to remain in their treatment program(s) until the end of the intervention portion of the study.
  • Able to provide written consent and comply with study procedures.
  • Meets the MINI 7 diagnostic criteria for either stimulant use disorder (SUD) or alcohol use disorder (AUD).

Exclusion Criteria:

  • Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, HIV)
  • Over 9 months of abstinence from substance use
  • A head injury resulting in a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI)
  • Presence of a condition that would render study measures difficult or impossible to administer or interpret
  • Age outside the range of 18 to 65
  • Primary current substance use disorder diagnosis (according to MINI 7 diagnostic criteria) for a substance other than stimulant or alcohol, except for caffeine or nicotine (Nicotine use will be recorded but is not exclusionary)
  • Entrance to the treatment program under a court mandate. (i.e. legally incarcerated)
  • History of ECT or cortical energy exposure within the past 6 months, including participation in any other neuromodulation studies

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): NCT04426214


Contacts
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Contact: Melanie Stimac 612-301-2449 stima011@umn.edu

Locations
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United States, Minnesota
University of Minnesota Fairview Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Melanie Stimac    612-301-2449    stima011@umn.edu   
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Kelvin Lim, MD University of Minnesota
  Study Documents (Full-Text)

Documents provided by University of Minnesota:
Informed Consent Form  [PDF] May 27, 2021

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04426214    
Other Study ID Numbers: PSYCH-2020-28848
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: July 18, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of Minnesota:
tDCS
Cognitive Training
Plasticity
Additional relevant MeSH terms:
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Substance-Related Disorders
Alcoholism
Chemically-Induced Disorders
Mental Disorders
Alcohol-Related Disorders