Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment

Oklahoma State University Center for Health Sciences

Status: Suspended

Conditions: Substance-Related Disorders

Treatments: Behavioral: Placebo Control; Behavioral: Cognitive Training

Study type: Interventional

Funder types: Other

Identifiers

NCT04404348

2018043

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive Training

Control

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Placebo Control