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Trial record 4 of 81 for:    Open Studies | "Occupational Therapy"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by University of California, San Francisco
Sponsor:
Collaborator:
San Francisco Veterans Administration Medical Center
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01684293
First received: September 10, 2012
Last updated: November 6, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Mild Cognitive Impairment, So Stated
Cocaine Use Disorder
Behavioral: Occupational therapy-based cognitive rehabilitation
Behavioral: Psychoeducation/games

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Occupational Therapy-Based Cognitive Rehabilitation of Cocaine Abusers: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Change in cognitive impairment [ Time Frame: baseline through 6 months ] [ Designated as safety issue: No ]
    Global Deficit Score, range 0 (no impairment) to 5 (severe impairment)


Estimated Enrollment: 20
Study Start Date: July 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Rehabilitation
Occupational therapy-based cognitive rehabilitation
Behavioral: Occupational therapy-based cognitive rehabilitation
Occupational therapy-based cognitive rehabilitation
Placebo Comparator: Psychoeducation/games
Psychoeducation/games
Behavioral: Psychoeducation/games
Psychoeducation/games

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684293

Contacts
Contact: Raj K Kalapatapu, MD 415-221-4810 ext 3075 rajkumar.kalapatapu@ucsf.edu

Locations
United States, California
University of California, San Francisco & San Francisco Veterans Affairs Medical Center Recruiting
San Francisco, California, United States, 94121
Contact: Raj K Kalapatapu, M.D.    415-221-4810 ext 3075    rajkumar.kalapatapu@ucsf.edu   
Principal Investigator: Raj K Kalapatapu, MD         
Sponsors and Collaborators
University of California, San Francisco
San Francisco Veterans Administration Medical Center
Investigators
Principal Investigator: Raj K Kalapatapu, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01684293     History of Changes
Other Study ID Numbers: 5K23DA034883-02
Study First Received: September 10, 2012
Last Updated: November 6, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by University of California, San Francisco:
Cocaine
Cognitive Impairment
Cognitive Rehabilitation

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Substance-Related Disorders
Chemically-Induced Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cocaine
Anesthetics
Anesthetics, Local
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 20, 2014