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Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04404348
Recruitment Status : Suspended (Study halted due to Covid-19 precautions)
First Posted : May 27, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Oklahoma State University Center for Health Sciences

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.


Condition or disease Intervention/treatment Phase
Substance-Related Disorders Behavioral: Cognitive Training Behavioral: Placebo Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment
Actual Study Start Date : March 6, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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 Name: 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.




Primary Outcome Measures :
  1. 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.

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04404348


Locations
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United States, Oklahoma
12&12, Inc
Tulsa, Oklahoma, United States, 74135
Sponsors and Collaborators
Oklahoma State University Center for Health Sciences
Investigators
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Principal Investigator: Alicia Ford, PhD Oklahoma State University Center for Health Sciences
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Responsible Party: Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier: NCT04404348    
Other Study ID Numbers: 2018043
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Opioid-Related Disorders
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Chemically-Induced Disorders