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Clinical Trials/NCT05001789
NCT05001789
Terminated
Not Applicable

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

New York State Psychiatric Institute1 site in 1 country13 target enrollmentSeptember 21, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid Use
Sponsor
New York State Psychiatric Institute
Enrollment
13
Locations
1
Primary Endpoint
NIH Toolbox Cognition Battery
Status
Terminated
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 21, 2021
End Date
June 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sandra D. Comer

Professor of Neurobiology

New York State Psychiatric Institute

Eligibility Criteria

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

Outcomes

Primary Outcomes

NIH Toolbox Cognition Battery

Time Frame: 3-month Follow up

A brief computerized test of key neuropsychological functions

Secondary Outcomes

  • Illicit Substance Use: Timeline Follow Back (TLFB)(3-month follow up)
  • Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF)(3-month follow up)
  • Quality of Life Scale (QOLS)(3-month follow up)
  • Impulsive decision making (Delay Discounting Task)(3-month follow up)

Study Sites (1)

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