Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment

Substance-Related Disorders Clinical Trial

Official title:

Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04404348
• Other study ID #: 2018043
• Status: Suspended
• Phase: N/A
• Start date: March 6, 2020
• Est. completion date: December 2020

Study information

• Verified date: September 2020
• Source: Oklahoma State University Center for Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 50
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Cognitive Training
Exercises used will be: Mind Bender, Divided Attention, Freeze Frame, Mixed Signals, Target Tracker, To Do List.
• Placebo Control
Games are drawn from the set of research control games provided by Posit Science-Brain HQ.

Locations

Country	Name	City	State
United States	12&12, Inc	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Oklahoma State University Center for Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Substance Abuse Program Completion Rate	Completion rate of recommended treatment program length, quantified as percentage completed	Until treatment program discharge, usually 30-45 days