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EEG/Event-related Brain Potential Risk Markers as Predictors and Outcomes of SUD Treatment in Adolescents

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02016378
Recruitment Status : Active, not recruiting
First Posted : December 20, 2013
Last Update Posted : January 14, 2020
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
University of Maryland, College Park
Information provided by (Responsible Party):
Brian Hicks, University of Michigan

Brief Summary:
This study investigates the effect of a computerized approach/avoidance retraining (aka cognitive bias modification) over and above treatment as usual for patients in treatment for substance use disorders. The computerized training entails viewing pictures of drug and non-drug related stimuli, and then using the computer to make the drug pictures smaller and the non-drug pictures larger. Participants will also take part in an EEG/event-related brain potential assessment at the beginning and end of treatment to identify brain measures that are associated with treatment response.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Behavioral: Bias retraining Behavioral: Sham retraining Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: EEG/Event-related Brain Potential Risk Markers as Predictors and Outcomes of SUD Treatment in Adolescents
Study Start Date : January 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: sham retraining
Participants in this condition will participate in a computerized task wherein the size of pictures of drug and non-drug related stimuli are increased or decreased based on the tilt (left or right) of the pictures, but without regard to the content (i.e., drug or non-drug).
Behavioral: Sham retraining
Participants will view pictures of drug and non-drug related stimuli on a computer. Participants will then use the computer to make the pictures larger or smaller based on the tilt of the picture (slightly to the left or right), but without regard to the content of the picture.

Active Comparator: Bias retraining
Participants in this condition will participate in 6 sessions of a computerized bias retraining.
Behavioral: Bias retraining
Participants will view pictures of drug (e.g., alcohol) and non-drug stimuli (e.g., soft drinks) on a computer. Participants will then use the computer to make the drug pictures smaller and the non-drug pictures larger.




Primary Outcome Measures :
  1. Change in Youth Outcome Questionnaire-Self-report scores [ Time Frame: baseline, 6 weeks and 6 months after the start of treatment ]
    This instrument is used to track symptoms throughout treatment. It will be used at baseline, 2x week for 2 weeks, 6 weeks from baseline (end of treatment), and at a 6 month follow-up assessment. The primary outcome is the growth curve of the scores over time.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patient in treatment for substance use disorders. Alcohol use problems. -

Exclusion Criteria:

Detoxification treatment. Severe mental illness (e.g., psychotic symptoms)

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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): NCT02016378


Locations
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United States, Michigan
University of Michigan Addiction Research Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institute on Drug Abuse (NIDA)
University of Maryland, College Park
Investigators
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Principal Investigator: Brian Hicks, PhD University of Michigan

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Responsible Party: Brian Hicks, Research Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02016378    
Other Study ID Numbers: 655655
R03DA034718 ( U.S. NIH Grant/Contract )
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders