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

Cocaine Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684293
• Other study ID #: 5K23DA034883-02
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: March 31, 2019

Study information

• Verified date: June 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Use Disorder
• Cognitive Dysfunction
• Mild Cognitive Impairment, So Stated

Intervention

Behavioral:
• Occupational therapy-based cognitive rehabilitation
Occupational therapy-based cognitive rehabilitation
• Psychoeducation/games
Psychoeducation/games

Locations

Country	Name	City	State
United States	University of California, San Francisco & San Francisco Veterans Affairs Medical Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	San Francisco Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognitive impairment	Global Deficit Score, range 0 (no impairment) to 5 (severe impairment)	baseline through 6 months