Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment

NCT ID: NCT04404348

Last Updated: 2020-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-06

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Substance-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Cognitive Training

Intervention Type BEHAVIORAL

Exercises used will be: Mind Bender, Divided Attention, Freeze Frame, Mixed Signals, Target Tracker, To Do List.

Control

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

Group Type PLACEBO_COMPARATOR

Placebo Control

Intervention Type BEHAVIORAL

Games are drawn from the set of research control games provided by Posit Science-Brain HQ.

Interventions

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Cognitive Training

Exercises used will be: Mind Bender, Divided Attention, Freeze Frame, Mixed Signals, Target Tracker, To Do List.

Intervention Type BEHAVIORAL

Placebo Control

Games are drawn from the set of research control games provided by Posit Science-Brain HQ.

Intervention Type BEHAVIORAL

Other Intervention Names

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Posit Science-Brain HQ

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oklahoma State University Center for Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alicia Ford, PhD

Role: PRINCIPAL_INVESTIGATOR

Oklahoma State University Center for Health Sciences

Locations

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12&12, Inc

Tulsa, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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2018043

Identifier Type: -

Identifier Source: org_study_id

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