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Completed

NCT Number: NCT01684293

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

San Francisco, California, 94121, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Occupational therapy-based cognitive rehabilitation

Behavioral

Occupational therapy-based cognitive rehabilitation

Psychoeducation/games

Behavioral

Psychoeducation/games

Primary outcomes

  1. Change in cognitive impairment

    Time frame: baseline through 6 months

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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • San Francisco Veterans Affairs Medical Center

Registry information

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Sep 12, 2012
Registry last updated
Jul 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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