Cognitive Functioning in Opioid Use Disorder

Study Overview
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Brief Summary
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This outpatient study is designed to examine the potential relationship between non-fatal opioid overdose and cognitive functioning. This study will also examine the impact of computerized working memory training on relevant outcomes (cognition, psychosocial functioning, quality of life, drug use). The training component of the study lasts 1 month, with follow up visits and 1-month and 3-months post training.

Detailed Description
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This outpatient study is designed to examine the potential relationship between non-fatal opioid overdose (i.e. overdose that does not result in death), cognitive functioning, and the impact of computerized working memory training on relevant outcomes (cognition, psychosocial functioning, quality of life). Participants (n=30) with a history of at least one prior opioid OD, who are enrolled in buprenorphine treatment, will be randomized to 20 sessions of an active (n=15) or sham (n=15) working memory training. Patients will complete measures of cognitive functioning during screening, post-training, and at 1-month and 3-month follow up. Participants will also complete the measures of decision making, psychosocial functioning and drug use at baseline, post-training, and follow up.

Official Title
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Cognitive Functioning in Opioid Use Disorder: Examining the Impacts of Computerized Working Memory Training and Non-Fatal Opioid Overdose

Conditions
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Opioid Use, Cognitive Change, Opioid-use Disorder

Intervention / Treatment
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* Other: CogMed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets DSM-5 criteria for moderate-severe Opioid Use Disorder (OUD) in the past 6 months Enrolled in a suboxone (buprenorphine/naloxone) program; willing to provide consent for research team to contact treatment provider History of at least 1 prior opioid overdose Recent history of illicit opioid use In good physical health Access to a smartphone, tablet, or computer Exclusion Criteria: Evidence of a co-occurring, untreated psychiatric condition that would make participation risky or difficulty Lack of access to a home computer, smartphone, or tablet Unable to speak, read and/or communicate in English

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Working memory training with task-difficulty increasing across sessions | Other: CogMed<br>* 20 sessions of Cogmed working memory training<br>|
| Active Comparator: Sham<br>Working memory training with task-difficulty remaining constant across sessions. | Other: CogMed<br>* 20 sessions of Cogmed working memory training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIH Toolbox Cognition Battery | A brief computerized test of key neuropsychological functions | Post-Training (1-month from baseline) | 
| NIH Toolbox Cognition Battery | A brief computerized test of key neuropsychological functions | 1-month Follow up | 
| NIH Toolbox Cognition Battery | A brief computerized test of key neuropsychological functions | 3-month Follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF) | B-IPF: scores range from 0 to 49 with higher scores indicating greater difficulties with psychosocial functioning | Post-training (1 month from baseline) | 
| Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF) | B-IPF: scores range from 0 to 49 with higher scores indicating greater difficulties with psychosocial functioning | 1-month follow up | 
| Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF) | B-IPF: scores range from 0 to 49 with higher scores indicating greater difficulties with psychosocial functioning | 3-month follow up | 
| Illicit Substance Use: Timeline Follow Back (TLFB) | TLFB: measures substance use in the past 1-week period | Post-training (1-month from baseline) | 
| Illicit Substance Use: Timeline Follow Back (TLFB) | TLFB: measures substance use in the past 1-week period | 1-month follow up | 
| Illicit Substance Use: Timeline Follow Back (TLFB) | TLFB: measures substance use in the past 1-week period | 3-month follow up | 
| Quality of Life Scale (QOLS) | QOLS: scores range from 16 to 112 with higher scores indicating greater quality of life | Post-training (1 month from baseline) | 
| Quality of Life Scale (QOLS) | QOLS: scores range from 16 to 112 with higher scores indicating greater quality of life | 1-month follow up | 
| Quality of Life Scale (QOLS) | QOLS: scores range from 16 to 112 with higher scores indicating greater quality of life | 3-month follow up | 
| Impulsive decision making (Delay Discounting Task) | Delay Discounting Task | Post-training (1 month from baseline) | 
| Impulsive decision making (Delay Discounting Task) | Delay Discounting Task | 1-month follow up | 
| Impulsive decision making (Delay Discounting Task) | Delay Discounting Task | 3-month follow up |