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Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment

Primary Purpose

Substance-Related Disorders

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Training
Placebo Control
Sponsored by
Oklahoma State University Center for Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance-Related Disorders

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has completed the detoxification process
  • Has completed at least 8 years of formal education
  • Speaks and reads English fluently
  • Is beginning residential inpatient treatment for opioid abuse (note: may be receiving treatment for polysubstance abuse but opioid must be one of their regular drugs of abuse)

Exclusion Criteria:

  • Unable to self-consent (has a proxy for medical decision-making, legal guardian, or been otherwise determined unable to give consent)
  • Past diagnosis or suspected current diagnosis of a neurodevelopmental disorder (e.g., autism, learning disability), attention-deficit disorder, or neurocognitive disorder (e.g., dementia)
  • History of major head trauma (defined as loss of consciousness for 30 minutes or longer) or brain surgery. (Note: History of concussion, including brief loss of consciousness, is okay)

Sites / Locations

  • 12&12, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

Three times per week for four weeks, participants will complete a computerized cognitive training session (approximately 30 minutes long).

Three times per week for four weeks, participants will complete a computerized session (approximately 30 minutes long) that consists of inert computer games.

Outcomes

Primary Outcome Measures

Mean Cognitive Change from Baseline to Endpoint
Change in overall cognitive summary score from pretest to posttest on NIH Toolbox.
Substance Abuse Program Completion Rate
Completion rate of recommended treatment program length, quantified as percentage completed

Secondary Outcome Measures

Full Information

First Posted
March 9, 2020
Last Updated
September 17, 2020
Sponsor
Oklahoma State University Center for Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04404348
Brief Title
Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment
Official Title
Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Suspended
Why Stopped
Study halted due to Covid-19 precautions
Study Start Date
March 6, 2020 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oklahoma State University Center for Health Sciences

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
Research has consistently found that cognitive impairment is common in persons with a history of substance abuse. The most commonly identified impairments across all substances are in attentional and working memory functioning and executive functioning; opioid-specific research finds that memory is an additional area of common impairment. Initial research in applying cognitive rehabilitation methods to substance abuse have shown it to be helpful overall. To develop a cognitive rehabilitation intervention that is effective for opioid abuse, this study will adapt a cognitive training program that has been shown to be effective in other patient groups. Patients in a residential opioid-abuse treatment program will undergo a cognitive evaluation and then be assigned to receive the 4-week cognitive intervention or the 4-week placebo control arm. It is expected that the intervention group will show greater gains on the cognitive post test and will have higher rated treatment adherence and opioid treatment program completion rates.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Three times per week for four weeks, participants will complete a computerized cognitive training session (approximately 30 minutes long).
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Three times per week for four weeks, participants will complete a computerized session (approximately 30 minutes long) that consists of inert computer games.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Other Intervention Name(s)
Posit Science-Brain HQ
Intervention Description
Exercises used will be: Mind Bender, Divided Attention, Freeze Frame, Mixed Signals, Target Tracker, To Do List.
Intervention Type
Behavioral
Intervention Name(s)
Placebo Control
Intervention Description
Games are drawn from the set of research control games provided by Posit Science-Brain HQ.
Primary Outcome Measure Information:
Title
Mean Cognitive Change from Baseline to Endpoint
Description
Change in overall cognitive summary score from pretest to posttest on NIH Toolbox.
Time Frame
Post-intervention at week 4
Title
Substance Abuse Program Completion Rate
Description
Completion rate of recommended treatment program length, quantified as percentage completed
Time Frame
Until treatment program discharge, usually 30-45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has completed the detoxification process Has completed at least 8 years of formal education Speaks and reads English fluently Is beginning residential inpatient treatment for opioid abuse (note: may be receiving treatment for polysubstance abuse but opioid must be one of their regular drugs of abuse) Exclusion Criteria: Unable to self-consent (has a proxy for medical decision-making, legal guardian, or been otherwise determined unable to give consent) Past diagnosis or suspected current diagnosis of a neurodevelopmental disorder (e.g., autism, learning disability), attention-deficit disorder, or neurocognitive disorder (e.g., dementia) History of major head trauma (defined as loss of consciousness for 30 minutes or longer) or brain surgery. (Note: History of concussion, including brief loss of consciousness, is okay)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alicia Ford, PhD
Organizational Affiliation
Oklahoma State University Center for Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
12&12, Inc
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment

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