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

NCT ID: NCT01684293

Last Updated: 2019-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2019-03-31

Brief Summary

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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

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

Conditions

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Mild Cognitive Impairment, So Stated Cocaine Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cognitive Rehabilitation

Occupational therapy-based cognitive rehabilitation

Group Type EXPERIMENTAL

Occupational therapy-based cognitive rehabilitation

Intervention Type BEHAVIORAL

Occupational therapy-based cognitive rehabilitation

Psychoeducation/games

Psychoeducation/games

Group Type PLACEBO_COMPARATOR

Psychoeducation/games

Intervention Type BEHAVIORAL

Psychoeducation/games

Interventions

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Occupational therapy-based cognitive rehabilitation

Occupational therapy-based cognitive rehabilitation

Intervention Type BEHAVIORAL

Psychoeducation/games

Psychoeducation/games

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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San Francisco Veterans Affairs Medical Center

FED

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raj K Kalapatapu, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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5K23DA034883-02

Identifier Type: NIH

Identifier Source: org_study_id

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