Mild Cognitive Impairment, So StatedNCT01684293
Occupational Therapy-Based Cognitive Rehabilitation of Cocaine Abusers: A Pilot Study
A study testing Occupational therapy-based cognitive rehabilitation and Psychoeducation/games in people with Mild Cognitive Impairment, So Stated and Cocaine Use Disorder, run by University of California, San Francisco at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mild Cognitive Impairment, So Stated, Cocaine Use Disorder
- What is being tested?
- Occupational therapy-based cognitive rehabilitation and Psychoeducation/games
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco & San Francisco Veterans Affairs Medical Center
San Francisco, California, 94121
About this 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.
Read the detailed description
occupational-therapy based cognitive rehabilitation as part of a comprehensive treatment plan for cocaine abusers
- Being tested
- Occupational therapy-based cognitive rehabilitation, Psychoeducation/games
- Keywords
- Cocaine, Cognitive Impairment, Cognitive Rehabilitation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational therapy-based cognitive rehabilitationBehavioural
Occupational therapy-based cognitive rehabilitation
Psychoeducation/gamesBehavioural
Psychoeducation/games
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Rehabilitation | Experimental | Occupational therapy-based cognitive rehabilitation Receives: Behavioral: Occupational therapy-based cognitive rehabilitation |
| Psychoeducation/games | Placebo comparator | Psychoeducation/games Receives: Behavioral: Psychoeducation/games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive impairment
Global Deficit Score, range 0 (no impairment) to 5 (severe impairment)
Measured: baseline through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startJul 2013
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment, So StatedStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco Veterans Affairs Medical Center
- Responsible party
- Sponsor
- Investigators
- Raj K Kalapatapu, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684293
- Sponsor's protocol ID
- 5K23DA034883-02
- Status last verified
- Jun 2019
- First submitted
- 10 Sep 2012
- Last updated
- 1 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Therapy-Based Cognitive Rehabilitation of Cocaine Abusers: A Pilot Study
- ClinicalTrials.gov ID
- NCT01684293
- Acronym / sponsor ID
- 5K23DA034883-02
- Keywords
- Cocaine, Cognitive Impairment, Cognitive Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- San Francisco Veterans Affairs Medical Center
- Study start
- Jul 2013
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 12 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
occupational-therapy based cognitive rehabilitation as part of a comprehensive treatment plan for cocaine abusers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Rehabilitation | Experimental | Behavioral: Occupational therapy-based cognitive rehabilitationOccupational therapy-based cognitive rehabilitation |
| Psychoeducation/games | Placebo comparator | Behavioral: Psychoeducation/gamesPsychoeducation/games |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational therapy-based cognitive rehabilitationOccupational therapy-based cognitive rehabilitation | Behavioural | Cognitive Rehabilitation |
| Psychoeducation/gamesPsychoeducation/games | Behavioural | Psychoeducation/games |
Primary outcome
Change in cognitive impairment
Time frame: baseline through 6 months
Global Deficit Score, range 0 (no impairment) to 5 (severe impairment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raj K Kalapatapu, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational therapy-based cognitive rehabilitation and Psychoeducation/games in people with Mild Cognitive Impairment, So Stated and Cocaine Use Disorder, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive impairment (time frame: baseline through 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2019.