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

NCT01684293 | Completed DMC

• 1 other identifier: 5K23DA034883-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment, So Stated; Cocaine Use Disorder

Keywords

Cocaine; Cognitive Impairment; Cognitive Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in cognitive impairment

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

  baseline through 6 months

Study Arms (2)

Cognitive Rehabilitation

EXPERIMENTAL

Occupational therapy-based cognitive rehabilitation

Behavioral: Occupational therapy-based cognitive rehabilitation

Psychoeducation/games

PLACEBO COMPARATOR

Psychoeducation/games

Behavioral: Psychoeducation/games

Interventions

Occupational therapy-based cognitive rehabilitation BEHAVIORAL

Occupational therapy-based cognitive rehabilitation

Cognitive Rehabilitation

Psychoeducation/games BEHAVIORAL

Psychoeducation/games

Psychoeducation/games

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• San Francisco Veterans Affairs Medical Center: collaborator

Study Sites (1)

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

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Raj K Kalapatapu, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2012
• First Posted: September 12, 2012
• Study Start: July 1, 2013
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: July 1, 2019

Record last verified: 2019-06

Locations

US (1)