Cognitive Functioning in Opioid Use Disorder

Opioid Use Clinical Trial

Official title:

Cognitive Functioning in Opioid Use Disorder: Examining the Impacts of Computerized Working Memory Training and Non-Fatal Opioid Overdose

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05001789
• Other study ID #: 8185
• Status: Suspended
• Phase: N/A
• Start date: September 21, 2021
• Est. completion date: November 30, 2024

Study information

• Verified date: August 2023
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 36
• Est. completion date: November 30, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Change
• Opioid Use
• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

Intervention

Other:
• CogMed
20 sessions of Cogmed working memory training

Locations

Country	Name	City	State
United States	NY State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NIH Toolbox Cognition Battery	A brief computerized test of key neuropsychological functions	Post-Training (1-month from baseline)
Primary	NIH Toolbox Cognition Battery	A brief computerized test of key neuropsychological functions	1-month Follow up
Primary	NIH Toolbox Cognition Battery	A brief computerized test of key neuropsychological functions	3-month Follow up
Secondary	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)
Secondary	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	1-month follow up
Secondary	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
Secondary	Illicit Substance Use: Timeline Follow Back (TLFB)	TLFB: measures substance use in the past 1-week period	Post-training (1-month from baseline)
Secondary	Illicit Substance Use: Timeline Follow Back (TLFB)	TLFB: measures substance use in the past 1-week period	1-month follow up
Secondary	Illicit Substance Use: Timeline Follow Back (TLFB)	TLFB: measures substance use in the past 1-week period	3-month follow up
Secondary	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)
Secondary	Quality of Life Scale (QOLS)	QOLS: scores range from 16 to 112 with higher scores indicating greater quality of life	1-month follow up
Secondary	Quality of Life Scale (QOLS)	QOLS: scores range from 16 to 112 with higher scores indicating greater quality of life	3-month follow up
Secondary	Impulsive decision making (Delay Discounting Task)	Delay Discounting Task	Post-training (1 month from baseline)
Secondary	Impulsive decision making (Delay Discounting Task)	Delay Discounting Task	1-month follow up
Secondary	Impulsive decision making (Delay Discounting Task)	Delay Discounting Task	3-month follow up