Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment

Sponsor
Oklahoma State University Center for Health Sciences (Other)
Overall Status
Suspended
CT.gov ID
NCT04404348
Collaborator
(none)
50
1
2
8.9
5.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Training
  • Behavioral: Placebo Control
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Mar 6, 2020
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Mean Cognitive Change from Baseline to Endpoint [Post-intervention at week 4]

      Change in overall cognitive summary score from pretest to posttest on NIH Toolbox.

    2. Substance Abuse Program Completion Rate [Until treatment program discharge, usually 30-45 days]

      Completion rate of recommended treatment program length, quantified as percentage completed

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 12&12, Inc Tulsa Oklahoma United States 74135

    Sponsors and Collaborators

    • Oklahoma State University Center for Health Sciences

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Oklahoma State University Center for Health Sciences
    ClinicalTrials.gov Identifier:
    NCT04404348
    Other Study ID Numbers:
    • 2018043
    First Posted:
    May 27, 2020
    Last Update Posted:
    Sep 18, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 18, 2020