Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment
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|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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.
- 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
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
|United States, Oklahoma|
|Tulsa, Oklahoma, United States, 74135|
|Principal Investigator:||Alicia Ford, PhD||Oklahoma State University Center for Health Sciences|