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

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.

Study Overview

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

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94121
      • University of California, San Francisco & San Francisco Veterans Affairs Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Rehabilitation; Occupational therapy-based cognitive rehabilitation	Behavioral: Occupational therapy-based cognitive rehabilitation; Occupational therapy-based cognitive rehabilitation
Placebo Comparator: Psychoeducation/games	Behavioral: Psychoeducation/games; Psychoeducation/games

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cognitive impairment	Global Deficit Score, range 0 (no impairment) to 5 (severe impairment)	baseline through 6 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: San Francisco Veterans Affairs Medical Center
• Investigators: Principal Investigator: Raj K Kalapatapu, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: September 10, 2012
• First Submitted That Met QC Criteria: September 10, 2012
• First Posted (Estimate): September 12, 2012

Study Record Updates

• Last Update Posted (Actual): July 1, 2019
• Last Update Submitted That Met QC Criteria: June 28, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Cognitive Impairment; Cognitive Rehabilitation; Cocaine
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 5K23DA034883-02 (U.S. NIH Grant/Contract)