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Cognitive Functioning in Opioid Use Disorder

Primary Purpose

Opioid Use, Cognitive Change, Opioid-use Disorder

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CogMed
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NY State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active

Sham

Arm Description

Working memory training with task-difficulty increasing across sessions

Working memory training with task-difficulty remaining constant across sessions.

Outcomes

Primary Outcome Measures

NIH Toolbox Cognition Battery
A brief computerized test of key neuropsychological functions
NIH Toolbox Cognition Battery
A brief computerized test of key neuropsychological functions
NIH Toolbox Cognition Battery
A brief computerized test of key neuropsychological functions

Secondary Outcome Measures

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
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
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
Illicit Substance Use: Timeline Follow Back (TLFB)
TLFB: measures substance use in the past 1-week period
Illicit Substance Use: Timeline Follow Back (TLFB)
TLFB: measures substance use in the past 1-week period
Illicit Substance Use: Timeline Follow Back (TLFB)
TLFB: measures substance use in the past 1-week period
Quality of Life Scale (QOLS)
QOLS: scores range from 16 to 112 with higher scores indicating greater quality of life
Quality of Life Scale (QOLS)
QOLS: scores range from 16 to 112 with higher scores indicating greater quality of life
Quality of Life Scale (QOLS)
QOLS: scores range from 16 to 112 with higher scores indicating greater quality of life
Impulsive decision making (Delay Discounting Task)
Delay Discounting Task
Impulsive decision making (Delay Discounting Task)
Delay Discounting Task
Impulsive decision making (Delay Discounting Task)
Delay Discounting Task

Full Information

First Posted
July 9, 2021
Last Updated
August 18, 2023
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05001789
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Suspended
Why Stopped
NYSPI-wide Institutional Research Pause as of June 12, 2023.
Study Start Date
September 21, 2021 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Cognitive Change, Opioid-use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Participants and research staff will be blinded to participant's training condition (active vs. sham)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
Working memory training with task-difficulty increasing across sessions
Arm Title
Sham
Arm Type
Active Comparator
Arm Description
Working memory training with task-difficulty remaining constant across sessions.
Intervention Type
Other
Intervention Name(s)
CogMed
Intervention Description
20 sessions of Cogmed working memory training
Primary Outcome Measure Information:
Title
NIH Toolbox Cognition Battery
Description
A brief computerized test of key neuropsychological functions
Time Frame
Post-Training (1-month from baseline)
Title
NIH Toolbox Cognition Battery
Description
A brief computerized test of key neuropsychological functions
Time Frame
1-month Follow up
Title
NIH Toolbox Cognition Battery
Description
A brief computerized test of key neuropsychological functions
Time Frame
3-month Follow up
Secondary Outcome Measure Information:
Title
Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF)
Description
B-IPF: scores range from 0 to 49 with higher scores indicating greater difficulties with psychosocial functioning
Time Frame
Post-training (1 month from baseline)
Title
Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF)
Description
B-IPF: scores range from 0 to 49 with higher scores indicating greater difficulties with psychosocial functioning
Time Frame
1-month follow up
Title
Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF)
Description
B-IPF: scores range from 0 to 49 with higher scores indicating greater difficulties with psychosocial functioning
Time Frame
3-month follow up
Title
Illicit Substance Use: Timeline Follow Back (TLFB)
Description
TLFB: measures substance use in the past 1-week period
Time Frame
Post-training (1-month from baseline)
Title
Illicit Substance Use: Timeline Follow Back (TLFB)
Description
TLFB: measures substance use in the past 1-week period
Time Frame
1-month follow up
Title
Illicit Substance Use: Timeline Follow Back (TLFB)
Description
TLFB: measures substance use in the past 1-week period
Time Frame
3-month follow up
Title
Quality of Life Scale (QOLS)
Description
QOLS: scores range from 16 to 112 with higher scores indicating greater quality of life
Time Frame
Post-training (1 month from baseline)
Title
Quality of Life Scale (QOLS)
Description
QOLS: scores range from 16 to 112 with higher scores indicating greater quality of life
Time Frame
1-month follow up
Title
Quality of Life Scale (QOLS)
Description
QOLS: scores range from 16 to 112 with higher scores indicating greater quality of life
Time Frame
3-month follow up
Title
Impulsive decision making (Delay Discounting Task)
Description
Delay Discounting Task
Time Frame
Post-training (1 month from baseline)
Title
Impulsive decision making (Delay Discounting Task)
Description
Delay Discounting Task
Time Frame
1-month follow up
Title
Impulsive decision making (Delay Discounting Task)
Description
Delay Discounting Task
Time Frame
3-month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
NY State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Cognitive Functioning in Opioid Use Disorder

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