Cognitive Functioning in Opioid Use Disorder: Examining the Impacts of Computerized Working Memory Training and Non-Fatal Opioid Overdose
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- NIH Toolbox Cognition Battery
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
Participants and research staff will be blinded to participant's training condition (active vs. sham)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Active
Working memory training with task-difficulty increasing across sessions
Intervention: CogMed (Other)
Sham
Working memory training with task-difficulty remaining constant across sessions.
Intervention: CogMed (Other)
Outcomes
Primary Outcomes
NIH Toolbox Cognition Battery
Time Frame: 3-month Follow up
A brief computerized test of key neuropsychological functions
NIH Toolbox Cognition Battery
Time Frame: Post-Training (1-month from baseline)
A brief computerized test of key neuropsychological functions
NIH Toolbox Cognition Battery
Time Frame: 1-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)
- 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)
- Illicit Substance Use: Timeline Follow Back (TLFB)(Post-training (1-month from baseline))
- Illicit Substance Use: Timeline Follow Back (TLFB)(1-month follow up)
- Quality of Life Scale (QOLS)(Post-training (1 month from baseline))
- Quality of Life Scale (QOLS)(1-month follow up)
- Impulsive decision making (Delay Discounting Task)(Post-training (1 month from baseline))
- Impulsive decision making (Delay Discounting Task)(1-month follow up)
Investigators
Sandra D. Comer
Professor of Neurobiology
New York State Psychiatric Institute