Cognitive Functioning in Opioid Use Disorder

NCT05001789 | Terminated

• 1 other identifier: 8185
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use; Cognitive Change; Opioid-use Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF)

  Post-training (1 month from baseline)

• Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF)

  1-month follow up

• Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF)

  3-month follow up

• Illicit Substance Use: Timeline Follow Back (TLFB)

  Post-training (1-month from baseline)

• Illicit Substance Use: Timeline Follow Back (TLFB)

  1-month follow up

Study Arms (2)

Active

EXPERIMENTAL

Working memory training with task-difficulty increasing across sessions

Other: CogMed

Sham

ACTIVE COMPARATOR

Working memory training with task-difficulty remaining constant across sessions.

Other: CogMed

Interventions

CogMed OTHER

20 sessions of Cogmed working memory training

Active; Sham

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

NY State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants and research staff will be blinded to participant's training condition (active vs. sham)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurobiology

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: August 12, 2021
• Study Start: September 21, 2021
• Primary Completion: June 3, 2024
• Study Completion: June 30, 2024
• Last Updated: March 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)