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

NCT02016378 | Completed Phase 3

• 2 other identifiers: 655655R03DA034718
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Youth Outcome Questionnaire-Self-report scores

  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.

  baseline, 6 weeks and 6 months after the start of treatment

Study Arms (2)

sham retraining

SHAM COMPARATOR

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

Bias retraining

ACTIVE COMPARATOR

Participants in this condition will participate in 6 sessions of a computerized bias retraining.

Behavioral: Bias retraining

Interventions

Bias retraining BEHAVIORAL

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.

Bias retraining

Sham retraining BEHAVIORAL

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.

sham retraining

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Drug Abuse (NIDA): collaborator
• University of Maryland: collaborator

Study Sites (1)

University of Michigan Addiction Research Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Brian Hicks, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: December 20, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 13, 2022

Record last verified: 2022-12

Locations

US (1)