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NYSPI-wide Institutional Research Pause as of June 12, 2023.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Working memory training with task-difficulty increasing across sessions |
|
| Sham | Active Comparator | Working memory training with task-difficulty remaining constant across sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CogMed | Other | 20 sessions of Cogmed working memory training |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF) | B-IPF: scores range from 0 to 49 with higher scores indicating greater difficulties with psychosocial functioning | Post-training (1 month from baseline) |
| Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NY State Psychiatric Institute | New York | New York | 10032 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 6, 2021 | Jul 15, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Participants and research staff will be blinded to participant's training condition (active vs. sham)
B-IPF: scores range from 0 to 49 with higher scores indicating greater difficulties with psychosocial functioning |
| 1-month follow up |
| Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF) | B-IPF: scores range from 0 to 49 with higher scores indicating greater difficulties with psychosocial functioning | 3-month follow up |
| Illicit Substance Use: Timeline Follow Back (TLFB) | TLFB: measures substance use in the past 1-week period | Post-training (1-month from baseline) |
| Illicit Substance Use: Timeline Follow Back (TLFB) | TLFB: measures substance use in the past 1-week period | 1-month follow up |
| Illicit Substance Use: Timeline Follow Back (TLFB) | TLFB: measures substance use in the past 1-week period | 3-month follow up |
| Quality of Life Scale (QOLS) | QOLS: scores range from 16 to 112 with higher scores indicating greater quality of life | Post-training (1 month from baseline) |
| Quality of Life Scale (QOLS) | QOLS: scores range from 16 to 112 with higher scores indicating greater quality of life | 1-month follow up |
| Quality of Life Scale (QOLS) | QOLS: scores range from 16 to 112 with higher scores indicating greater quality of life | 3-month follow up |
| Impulsive decision making (Delay Discounting Task) | Delay Discounting Task | Post-training (1 month from baseline) |
| Impulsive decision making (Delay Discounting Task) | Delay Discounting Task | 1-month follow up |
| Impulsive decision making (Delay Discounting Task) | Delay Discounting Task | 3-month follow up |