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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT05001789
Other study ID # 8185
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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