Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment

September 17, 2020 updated by: Oklahoma State University Center for Health Sciences

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • 12&12, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Three times per week for four weeks, participants will complete a computerized cognitive training session (approximately 30 minutes long).
Behavioral: Cognitive Training
Exercises used will be: Mind Bender, Divided Attention, Freeze Frame, Mixed Signals, Target Tracker, To Do List.
Other Names:
  • Posit Science-Brain HQ
Placebo Comparator: Control
Three times per week for four weeks, participants will complete a computerized session (approximately 30 minutes long) that consists of inert computer games.
Behavioral: Placebo Control
Games are drawn from the set of research control games provided by Posit Science-Brain HQ.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Cognitive Change from Baseline to Endpoint
Time Frame: Post-intervention at week 4
Change in overall cognitive summary score from pretest to posttest on NIH Toolbox.
Post-intervention at week 4
Substance Abuse Program Completion Rate
Time Frame: Until treatment program discharge, usually 30-45 days
Completion rate of recommended treatment program length, quantified as percentage completed
Until treatment program discharge, usually 30-45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oklahoma State University Center for Health Sciences

Investigators

  • Principal Investigator: Alicia Ford, PhD, Oklahoma State University Center for Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

May 26, 2020

First Posted (Actual)

May 27, 2020

Study Record Updates

Last Update Posted (Actual)

September 18, 2020

Last Update Submitted That Met QC Criteria

September 17, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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