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

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ClinicalTrials.gov Identifier: NCT01684293
Recruitment Status : Recruiting
First Posted : September 12, 2012
Last Update Posted : November 7, 2017
Sponsor:
Collaborator:
San Francisco Veterans Affairs Medical Center
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Mild Cognitive Impairment, So Stated Cocaine Use Disorder 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  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Occupational Therapy-Based Cognitive Rehabilitation of Cocaine Abusers: A Pilot Study
Study Start Date : July 2013
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

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
Psychoeducation/games
Behavioral: Psychoeducation/games
Psychoeducation/games



Primary Outcome Measures :
  1. Change in cognitive impairment [ Time Frame: baseline through 6 months ]
    Global Deficit Score, range 0 (no impairment) to 5 (severe impairment)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684293


Contacts
Contact: Raj K Kalapatapu, MD 415-221-4810 ext 23075 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 23075    rajkumar.kalapatapu@ucsf.edu   
Principal Investigator: Raj K Kalapatapu, MD         
Sponsors and Collaborators
University of California, San Francisco
San Francisco Veterans Affairs Medical Center
Investigators
Principal Investigator: Raj K Kalapatapu, MD University of California, San Francisco

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01684293     History of Changes
Other Study ID Numbers: 5K23DA034883-02 ( U.S. NIH Grant/Contract )
First Posted: September 12, 2012    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017

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

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents