Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment

NCT04404348 | Suspended

• 1 other identifier: 2018043
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance-Related Disorders

Outcome Measures

Primary Outcomes (2)

• Mean Cognitive Change from Baseline to Endpoint

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

  Post-intervention at week 4

• Substance Abuse Program Completion Rate

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

  Until treatment program discharge, usually 30-45 days

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Cognitive Training

Control

PLACEBO COMPARATOR

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

Interventions

Cognitive Training BEHAVIORAL

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

Also known as: Posit Science-Brain HQ

Intervention

Placebo Control BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oklahoma State University Center for Health Sciences: lead

Study Sites (1)

12&12, Inc

Tulsa, Oklahoma, 74135, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Alicia Ford, PhD

  Oklahoma State University Center for Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: May 27, 2020
• Study Start: March 6, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 18, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)