Occupational Therapy-Based Cognitive Rehabilitation of Cocaine Abusers: A Pilot Study

Not Applicable

Completed

• Conditions: Cocaine Use Disorder; Mild Cognitive Impairment, So Stated
• Interventions: Behavioral: Psychoeducation/games; Behavioral: Occupational therapy-based cognitive rehabilitation

• Registration Number: NCT01684293
• Lead Sponsor: University of California, San Francisco

Brief Summary

This study integrates a model of occupational-therapy based cognitive rehabilitation as part of a comprehensive treatment plan for cocaine abusers. We hypothesize that cognitive impairment and quality of life would improve and that cocaine use would decrease in those participants receiving occupational-therapy based cognitive rehabilitation.

Detailed Description

occupational-therapy based cognitive rehabilitation as part of a comprehensive treatment plan for cocaine abusers

Study Timeline

• Study First Submitted: 2012-09-10
• Study First Submitted QC: 2012-09-10
• Study First Posted: 2012-09-12
• Study Start: 2013-07
• Primary Completion: 2019-03-31
• Study Completion: 2019-03-31
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-28
• Last Update Posted: 2019-07-01

Recruitment & Eligibility

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

Inclusion Criteria

1. Age 18-65
2. Primary cocaine use disorder (based on DSM-5 criteria) and in at least 3 months of remission
3. At least mild cognitive impairment, defined as = or > 1.5 standard deviations impairment on any 2 performance-based neurocognitive measures
4. Needing to change quality of life, defined as self-identifying at least 2 life areas as needing to change on the Drug User Quality of Life Scale
5. A Veteran at the San Francisco Veterans Affairs Medical Center
6. Currently receiving weekly drug counseling (individual or group; at least 1 hour/week) through an outpatient substance use disorder treatment program

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Exclusion Criteria

1. Inability to speak, read, write, and understand English
2. Inadequate hearing or vision
3. Concurrent substance use disorder (except tobacco or caffeine) not in at least 3 months of remission
4. A psychiatric disorder that will interfere with study participation or will make participation hazardous (e.g., psychosis, suicidal or homicidal ideations, severe anxiety)
5. A depressive disorder classified as severe, defined as a Beck Depression Inventory-II score >29
6. Current diagnosis of a bipolar disorder needing acute inpatient psychiatric hospitalization
7. Currently symptomatic from attention-deficit/hyperactivity disorder (DSM-5 criteria)
8. Any learning disorder, any type of dementia, any type of delirium, or an amnestic disorder due to any general medical condition
9. Wechsler Test of Adult Reading standard score <70
10. Mini-Mental State Examination score <24
11. Current use of scheduled (i.e., prescribed) regular (i.e., daily) psychotropics or other medicines with a high likelihood of sedation & cognitive impairment (e.g., benzodiazepines, clozapine, anticholinergics)
12. Currently prescribed stimulants (e.g., methylphenidate) or cognitive enhancers (e.g., donepezil, memantine)
13. Active medical illnesses - uncontrolled diabetes, uncontrolled hypertension, uncontrolled thyroid dysfunction, or uncontrolled B12/folate deficiency; central nervous system illness with potential cognitive aspects (Parkinson's, or Huntington's dementia); Cirrhosis with complications (e.g., ascites, encephalopathy, jaundice, gastrointestinal bleeding); Needing acute medical hospitalization from HIV sequelae, such as HIV-related opportunistic infection
14. Any history of any type of stroke or brain hemorrhage
15. Any history of traumatic brain injury, intracranial pathology (e.g., tumor), or brain surgery
16. Currently on probation or parole
17. Concurrent participation in another study that medically/administratively interferes with this study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychoeducation/games	Psychoeducation/games	Psychoeducation/games
Cognitive Rehabilitation	Occupational therapy-based cognitive rehabilitation	Occupational therapy-based cognitive rehabilitation

Primary Outcome Measures

Name	Time	Method
Change in cognitive impairment	baseline through 6 months	Global Deficit Score, range 0 (no impairment) to 5 (severe impairment)

Trial Locations

Locations (1)

University of California, San Francisco & San Francisco Veterans Affairs Medical Center; 🇺🇸 San Francisco, California, United States