Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment

Study Overview
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Brief Summary
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Research has consistently found that cognitive impairment is common in persons with a history of substance abuse. The most commonly identified impairments across all substances are in attentional and working memory functioning and executive functioning; opioid-specific research finds that memory is an additional area of common impairment. Initial research in applying cognitive rehabilitation methods to substance abuse have shown it to be helpful overall. To develop a cognitive rehabilitation intervention that is effective for opioid abuse, this study will adapt a cognitive training program that has been shown to be effective in other patient groups. Patients in a residential opioid-abuse treatment program will undergo a cognitive evaluation and then be assigned to receive the 4-week cognitive intervention or the 4-week placebo control arm. It is expected that the intervention group will show greater gains on the cognitive post test and will have higher rated treatment adherence and opioid treatment program completion rates.

Official Title
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Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment

Conditions
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Substance-Related Disorders

Intervention / Treatment
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* Behavioral: Cognitive Training
* Behavioral: Placebo Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has completed the detoxification process Has completed at least 8 years of formal education Speaks and reads English fluently Is beginning residential inpatient treatment for opioid abuse (note: may be receiving treatment for polysubstance abuse but opioid must be one of their regular drugs of abuse) Exclusion Criteria: Unable to self-consent (has a proxy for medical decision-making, legal guardian, or been otherwise determined unable to give consent) Past diagnosis or suspected current diagnosis of a neurodevelopmental disorder (e.g., autism, learning disability), attention-deficit disorder, or neurocognitive disorder (e.g., dementia) History of major head trauma (defined as loss of consciousness for 30 minutes or longer) or brain surgery. (Note: History of concussion, including brief loss of consciousness, is okay)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Three times per week for four weeks, participants will complete a computerized cognitive training session (approximately 30 minutes long). | Behavioral: Cognitive Training<br>* Exercises used will be: Mind Bender, Divided Attention, Freeze Frame, Mixed Signals, Target Tracker, To Do List.<br>* Other names: Posit Science-Brain HQ;|
| Placebo Comparator: Control<br>Three times per week for four weeks, participants will complete a computerized session (approximately 30 minutes long) that consists of inert computer games. | Behavioral: Placebo Control<br>* Games are drawn from the set of research control games provided by Posit Science-Brain HQ.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Cognitive Change from Baseline to Endpoint | Change in overall cognitive summary score from pretest to posttest on NIH Toolbox. | Post-intervention at week 4 | 
| Substance Abuse Program Completion Rate | Completion rate of recommended treatment program length, quantified as percentage completed | Until treatment program discharge, usually 30-45 days |