Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment

Not Applicable

Suspended

• Conditions: Substance-Related Disorders

• Registration Number: NCT04404348
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-06
• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-27
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-17
• Last Update Posted: 2020-09-18
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.
Substance Abuse Program Completion Rate	Until treatment program discharge, usually 30-45 days	Completion rate of recommended treatment program length, quantified as percentage completed

Trial Locations

Locations (1)

12&12, Inc; 🇺🇸 Tulsa, Oklahoma, United States