Clinical trial NCT05001789: Cognitive Functioning in Opioid Use Disorder
Official title: Cognitive Functioning in Opioid Use Disorder: Examining the Impacts of Computerized Working Memory Training and Non-Fatal Opioid Overdose
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Opioid Use
Cognitive Change
Opioid-use Disorder
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: NIH Toolbox Cognition Battery
timeFrame: Post-Training (1-month from baseline)
measure: NIH Toolbox Cognition Battery
timeFrame: 1-month Follow up
measure: NIH Toolbox Cognition Battery
timeFrame: 3-month Follow up
Secondary outcomes:
measure: Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF)
timeFrame: Post-training (1 month from baseline)
measure: Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF)
timeFrame: 1-month follow up
measure: Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF)
timeFrame: 3-month follow up
measure: Illicit Substance Use: Timeline Follow Back (TLFB)
timeFrame: Post-training (1-month from baseline)
measure: Illicit Substance Use: Timeline Follow Back (TLFB)
timeFrame: 1-month follow up
measure: Illicit Substance Use: Timeline Follow Back (TLFB)
timeFrame: 3-month follow up
measure: Quality of Life Scale (QOLS)
timeFrame: Post-training (1 month from baseline)
measure: Quality of Life Scale (QOLS)
timeFrame: 1-month follow up
measure: Quality of Life Scale (QOLS)
timeFrame: 3-month follow up
measure: Impulsive decision making (Delay Discounting Task)
timeFrame: Post-training (1 month from baseline)
measure: Impulsive decision making (Delay Discounting Task)
timeFrame: 1-month follow up
measure: Impulsive decision making (Delay Discounting Task)
timeFrame: 3-month follow up
Other outcomes:
Locations:
city: New York
country: United States
facility: NY State Psychiatric Institute
state: New York
Study officials:
References: