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Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment

O

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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