Cognitive Change, Opioid Use, Opioid-use Disorder
Conditions
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.
Interventions
OTHERCogMed
20 sessions of Cogmed working memory training
Sponsors
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Participants and research staff will be blinded to participant's training condition (active vs. sham)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NIH Toolbox Cognition Battery | Post-Training (1-month from baseline) | A brief computerized test of key neuropsychological functions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF) | Post-training (1 month from baseline) | B-IPF: scores range from 0 to 49 with higher scores indicating greater difficulties with psychosocial functioning |
| Illicit Substance Use: Timeline Follow Back (TLFB) | Post-training (1-month from baseline) | TLFB: measures substance use in the past 1-week period |
| Quality of Life Scale (QOLS) | Post-training (1 month from baseline) | QOLS: scores range from 16 to 112 with higher scores indicating greater quality of life |
| Impulsive decision making (Delay Discounting Task) | Post-training (1 month from baseline) | Delay Discounting Task |
Countries
United States
Outcome results
None listed