Cognitive Functioning in Opioid Use Disorder

Not Applicable

Terminated

• Conditions: Opioid-use Disorder; Opioid Use; Cognitive Change

• Registration Number: NCT05001789
• Lead Sponsor: New York State Psychiatric Institute

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-12
• Study Start: 2021-09-21
• Primary Completion: 2024-06-03
• Study Completion: 2024-06-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
NIH Toolbox Cognition Battery	3-month Follow up	A brief computerized test of key neuropsychological functions

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NY State Psychiatric Institute; 🇺🇸 New York, New York, United States