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

Primary Purpose

Mild Cognitive Impairment, So Stated, Cocaine Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Occupational therapy-based cognitive rehabilitation
Psychoeducation/games
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment, So Stated focused on measuring Cocaine, Cognitive Impairment, Cognitive Rehabilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cognitive Rehabilitation

Psychoeducation/games

Arm Description

Occupational therapy-based cognitive rehabilitation

Psychoeducation/games

Outcomes

Primary Outcome Measures

Change in cognitive impairment
Global Deficit Score, range 0 (no impairment) to 5 (severe impairment)

Secondary Outcome Measures

Full Information

First Posted
September 10, 2012
Last Updated
June 28, 2019
Sponsor
University of California, San Francisco
Collaborators
San Francisco Veterans Affairs Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01684293
Brief Title
Occupational Therapy-Based Cognitive Rehabilitation of Cocaine Abusers: A Pilot Study
Official Title
Occupational Therapy-Based Cognitive Rehabilitation of Cocaine Abusers: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
San Francisco Veterans Affairs Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, So Stated, Cocaine Use Disorder
Keywords
Cocaine, Cognitive Impairment, Cognitive Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Rehabilitation
Arm Type
Experimental
Arm Description
Occupational therapy-based cognitive rehabilitation
Arm Title
Psychoeducation/games
Arm Type
Placebo Comparator
Arm Description
Psychoeducation/games
Intervention Type
Behavioral
Intervention Name(s)
Occupational therapy-based cognitive rehabilitation
Intervention Description
Occupational therapy-based cognitive rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation/games
Intervention Description
Psychoeducation/games
Primary Outcome Measure Information:
Title
Change in cognitive impairment
Description
Global Deficit Score, range 0 (no impairment) to 5 (severe impairment)
Time Frame
baseline through 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-65 Primary cocaine use disorder (based on DSM-5 criteria) and in at least 3 months of remission At least mild cognitive impairment, defined as = or > 1.5 standard deviations impairment on any 2 performance-based neurocognitive measures 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 A Veteran at the San Francisco Veterans Affairs Medical Center Currently receiving weekly drug counseling (individual or group; at least 1 hour/week) through an outpatient substance use disorder treatment program Exclusion Criteria: Inability to speak, read, write, and understand English Inadequate hearing or vision Concurrent substance use disorder (except tobacco or caffeine) not in at least 3 months of remission A psychiatric disorder that will interfere with study participation or will make participation hazardous (e.g., psychosis, suicidal or homicidal ideations, severe anxiety) A depressive disorder classified as severe, defined as a Beck Depression Inventory-II score >29 Current diagnosis of a bipolar disorder needing acute inpatient psychiatric hospitalization Currently symptomatic from attention-deficit/hyperactivity disorder (DSM-5 criteria) Any learning disorder, any type of dementia, any type of delirium, or an amnestic disorder due to any general medical condition Wechsler Test of Adult Reading standard score <70 Mini-Mental State Examination score <24 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) Currently prescribed stimulants (e.g., methylphenidate) or cognitive enhancers (e.g., donepezil, memantine) 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 Any history of any type of stroke or brain hemorrhage Any history of traumatic brain injury, intracranial pathology (e.g., tumor), or brain surgery Currently on probation or parole Concurrent participation in another study that medically/administratively interferes with this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raj K Kalapatapu, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco & San Francisco Veterans Affairs Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States

12. IPD Sharing Statement

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

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