Cognitive Functioning in Opioid Use Disorder

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

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.

Study Overview

• Status: Terminated
• Conditions: Cognitive Change; Opioid Use; Opioid-use Disorder
• Intervention / Treatment: Other: CogMed

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • NY State Psychiatric Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2021
• Primary Completion (Actual): June 3, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Substance-Related Disorders
• Other Study ID Numbers: 8185

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No