Cocaine DependenceNCT01914835
Neuropsychological Rehabilitation on Cocaine/Crack Dependents
A study testing Motivational Chess in people with Cocaine Dependence, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Cocaine/Crack Dependence has been associated with neuropsychological impairments mainly in executive functions and decision-making, which are predominantly managed by the prefrontal cortex (PFC) in the brain. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- Motivational Chess
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2011to Oct 2017
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meet the DSM-IV-TR (APA, 2003) criteria for substance dependence through SCID
- Age from18 to 45 years
- Estimated intelligence average or above (≥ 80 IQ)
- Minimum Education: complete basic education (up to fourth grade).
Who cannot join
- Diagnostic of comorbidity with Axis I psychiatric disorders such as Schizophrenia, Dementia, Major Depression (Severe) and Bipolar Affective Disorder (BD)
- History of head trauma with loss of consciousness for a period longer than one hour and / or other neurological problems;
- Medical conditions that compromise in any way the central nervous system;
- Subjects who are not in 3 to 7 days of abstinence.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of São Paulo, Institute of Psychiatry
São Paulo, São Paulo
About this study
Official title: The Impact of Neuropsychological Rehabilitation on Cocaine/Crack Dependents: a Placebo-controlled Study Using Cognitive Tests and Functional Magnetic Resonance Imaging.
Cocaine/Crack Dependence has been associated with neuropsychological impairments mainly in executive functions and decision-making, which are predominantly managed by the prefrontal cortex (PFC) in the brain. However, none study in Neuropsychological Rehabilitation (NR) has been done in order to remediate the executive functioning in this population. The aim of this research is to investigate the impact of neuropsychological intervention based on the stimulation of cognitive functions such as attention, planning, organization, logical reasoning, executive functioning, and decision making. For this research it will be proposed interventions through motivational strategies and board games, especially chess because it has been associated with PFC functioning, since it is a game which requires complex cognitive abilities, such as: inhibitory control, mental flexibility, sustained attention, future planning and decision-making. There will be two groups of patients with cocaine/crack dependence (n = 56), one with NR (group A, n = 28) and another without NR (group B, n = 28). Group B will be submitted to the placebo intervention. Both groups will be submitted to an extensive battery of neuropsychological tests and psychopathological rating scales before and after interventions. A sub-group will also be submitted to functional magnetic resonance imaging and biomarkers measures (BDNF and cortisol). The hypothesis is that group A will present a pronounced improvement not only on the neuropsychological test but also on the PFC functioning in neuropsychological functions compared to group B.
Read the detailed description
Cognitive Stimulation - The Motivational Chess (MC) was designed to stimulate executive cognitive functioning. The idea of combining Motivational Interviewing (25) with chess game was to stimulate discrepancy, motivation, and support self-efficacy. Volunteers will be submitted to 10 sessions of 90 minutes, over three weeks (total 15 hours: 10 hours of chess practice and 5 hours of motivational interviewing). At the beginning of each session the participants will be divided into pairs and received a sheet containing the game rules (that sheet worked as a kind of working memory aid). During the game practice, there will be a therapist (coordinator) observing, helping, and motivating the participants for goal-directed behaviors. The therapist interventions will be focused on patient's behavior, analyzing if they know the game rules, are able to follow the rules, have visual perception of the pieces, and use strategies considering short or long-term consequences. Another relevant role of the therapist will be empathic with the patients and to help them deal with their own resistance to change or to adapt to new situations.
The last 30 minutes of MC will be divided into three stages: 1) a short presentation on the cognitive deficits due to CD (Giving Information); 2) participants will report their impressions about their performance in chess linking it to real life situations such as drug-related events, difficulty monitoring and directing behavior, controlling craving and relapse (Developing Discrepancy); 3) discussions encouraging healthy decision making, focusing on future and favorable real-life long-term behaviors, as opposed to immediate and high risk behaviors (Supporting Self-Efficacy).
Control Group - The Active Control (AC) group will occur exactly on the same conditions of the MC group. It consists of one hour of recreational activities to stimulate more basic cognitive functions, such as simple attention (for example, to follow a simple sequence of actions), motor coordination and visual functions. Ten activities were structured using cardboard, paper, crayons, among others. In the last 30 minutes, there will be a presentation also based on Motivational Interviewing, but limited to providing information about basic cognitive functions (Giving Information) and promoting motivation to engagement to the activities.
Procedures To enroll in this study, the participants must have a positive urine test for cocaine and will answer to semi-structured clinical interviews (SCID and ASI-6) on the first week. When the urine test becomes negative (mean in days: 9.48 ± 3.06), the pre assessment will be applied (Neuropsychological and Psychopathological Assessment, Functional Magnetic Resonance Imaging, Brain-derived neurotrophic factor levels and Cortisol levels) . Then the participants will participate in 10 sessions of MC or AC for approximately 3 weeks. At the end, if the urine test remains negative, the post assessment will be applied (about one month of abstinence of cocaine use). The urine toxicology test will be used to have an objective measure of recent use and abstinence.
- Conditions
- Cocaine Dependence
- Being tested
- Motivational Chess
- Keywords
- cocaine dependence, neuropsychological rehabilitation, executive functions
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational ChessBehavioural
Also called Cognitive stimulation, Neuropsychological reahabilitation
The Motivational Chess (MC) combines Motivational Interviewing with chess game. Volunteers are submitted to 10 sessions of 90 minutes, over three weeks (total 15 hours: 10 hours of chess practice and 5 hours of motivational interviewing).
The Active Control (AC) group consists of ten structured activities using cardboard, paper, crayons, among others. Volunteers are submitted to 10 sessions of 90 minutes, over three weeks (total 15 hours: 10 hours of recreational activities and 5 hours of information about basic cognitive functions).
| Study group | Role | What they receive |
|---|---|---|
| Motivational Chess & Active Control | Experimental | Ten meetings of 90 minutes each. Receives: Behavioral: Motivational Chess |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological tests
Trail Making Test, Stroop Color Test, Wisconsin Card Sorting Test, Behavioral Assessment of the Dysexecutive Syndrome, Digit Span Test, Iowa Gambling Test, Spatial Addition (Wechsler Memory Scale), Frontal Assessment Battery, Rey Complex Figure.
Measured: three weeks
Secondary outcomes (1)
Psychopathological rating scales
Beck Depression Inventory, State-Trait Anxiety Inventory for Adults, Social Adjustment Scale, Barratt Impulsiveness Scale (BIS 11), World Health Organization Quality of Life Bref (WHOQOF).
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startApr 2011
- Primary completionApr 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, prisciladib, University of Sao Paulo General Hospital
- Investigators
- Arthur G de Andrade, M.D., Ph.D, Principal investigator, Program of the Interdisciplinary Group of Studies on Alcohol and Drugs (GREA), School of Medicine, Institute and Department of Psychiatry, University of Sao Paulo - USP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914835
- Sponsor's protocol ID
- CNPq, Grant 402721/2010-1
- Status last verified
- May 2016
- First submitted
- 22 Apr 2013
- Last updated
- 26 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Goncalves PD, Ometto M, Bechara A, Malbergier A, Amaral R, Nicastri S, Martins PA, Beraldo L, dos Santos B, Fuentes D, Andrade AG, Busatto GF, Cunha PJ. Motivational interviewing combined with chess accelerates improvement in executive functions in cocaine dependent patients: a one-month prospective study. Drug Alcohol Depend. 2014 Aug 1;141:79-84. doi: 10.1016/j.drugalcdep.2014.05.006. Epub 2014 May 24.
PubMed 24913200
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Neuropsychological Rehabilitation on Cocaine/Crack Dependents: a Placebo-controlled Study Using Cognitive Tests and Functional Magnetic Resonance Imaging.
- ClinicalTrials.gov ID
- NCT01914835
- Acronym / sponsor ID
- CNPq, Grant 402721/2010-1
- Conditions
- Cocaine Dependence
- Keywords
- cocaine dependence, neuropsychological rehabilitation, executive functions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Apr 2011
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 2 Aug 2013 (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.
Cocaine/Crack Dependence has been associated with neuropsychological impairments mainly in executive functions and decision-making, which are predominantly managed by the prefrontal cortex (PFC) in the brain. However, none study in Neuropsychological Rehabilitation (NR) has been done in order to remediate the executive functioning in this population. The aim of this research is to investigate the impact of neuropsychological intervention based on the stimulation of cognitive functions such as attention, planning, organization, logical reasoning, executive functioning, and decision making. For this research it will be proposed interventions through motivational strategies and board games, especially chess because it has been associated with PFC functioning, since it is a game which requires complex cognitive abilities, such as: inhibitory control, mental flexibility, sustained attention, future planning and decision-making. There will be two groups of patients with cocaine/crack dependence (n = 56), one with NR (group A, n = 28) and another without NR (group B, n = 28). Group B will be submitted to the placebo intervention. Both groups will be submitted to an extensive battery of neuropsychological tests and psychopathological rating scales before and after interventions. A sub-group will also be submitted to functional magnetic resonance imaging and biomarkers measures (BDNF and cortisol). The hypothesis is that group A will present a pronounced improvement not only on the neuropsychological test but also on the PFC functioning in neuropsychological functions compared to group B.
Detailed description
Cognitive Stimulation - The Motivational Chess (MC) was designed to stimulate executive cognitive functioning. The idea of combining Motivational Interviewing (25) with chess game was to stimulate discrepancy, motivation, and support self-efficacy. Volunteers will be submitted to 10 sessions of 90 minutes, over three weeks (total 15 hours: 10 hours of chess practice and 5 hours of motivational interviewing). At the beginning of each session the participants will be divided into pairs and received a sheet containing the game rules (that sheet worked as a kind of working memory aid). During the game practice, there will be a therapist (coordinator) observing, helping, and motivating the participants for goal-directed behaviors. The therapist interventions will be focused on patient's behavior, analyzing if they know the game rules, are able to follow the rules, have visual perception of the pieces, and use strategies considering short or long-term consequences. Another relevant role of the therapist will be empathic with the patients and to help them deal with their own resistance to change or to adapt to new situations.
The last 30 minutes of MC will be divided into three stages: 1) a short presentation on the cognitive deficits due to CD (Giving Information); 2) participants will report their impressions about their performance in chess linking it to real life situations such as drug-related events, difficulty monitoring and directing behavior, controlling craving and relapse (Developing Discrepancy); 3) discussions encouraging healthy decision making, focusing on future and favorable real-life long-term behaviors, as opposed to immediate and high risk behaviors (Supporting Self-Efficacy).
Control Group - The Active Control (AC) group will occur exactly on the same conditions of the MC group. It consists of one hour of recreational activities to stimulate more basic cognitive functions, such as simple attention (for example, to follow a simple sequence of actions), motor coordination and visual functions. Ten activities were structured using cardboard, paper, crayons, among others. In the last 30 minutes, there will be a presentation also based on Motivational Interviewing, but limited to providing information about basic cognitive functions (Giving Information) and promoting motivation to engagement to the activities.
Procedures To enroll in this study, the participants must have a positive urine test for cocaine and will answer to semi-structured clinical interviews (SCID and ASI-6) on the first week. When the urine test becomes negative (mean in days: 9.48 ± 3.06), the pre assessment will be applied (Neuropsychological and Psychopathological Assessment, Functional Magnetic Resonance Imaging, Brain-derived neurotrophic factor levels and Cortisol levels) . Then the participants will participate in 10 sessions of MC or AC for approximately 3 weeks. At the end, if the urine test remains negative, the post assessment will be applied (about one month of abstinence of cocaine use). The urine toxicology test will be used to have an objective measure of recent use and abstinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motivational Chess & Active Control | Experimental | Behavioral: Motivational ChessTen meetings of 90 minutes each. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Meet the DSM-IV-TR (APA, 2003) criteria for substance dependence through SCID
- Age from18 to 45 years
- Estimated intelligence average or above (≥ 80 IQ)
- Minimum Education: complete basic education (up to fourth grade).
Key exclusion criteria (4 listed)
- Diagnostic of comorbidity with Axis I psychiatric disorders such as Schizophrenia, Dementia, Major Depression (Severe) and Bipolar Affective Disorder (BD)
- History of head trauma with loss of consciousness for a period longer than one hour and / or other neurological problems;
- Medical conditions that compromise in any way the central nervous system;
- Subjects who are not in 3 to 7 days of abstinence.
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 |
|---|---|---|
| Motivational ChessAlso: Cognitive stimulation, Neuropsychological reahabilitationThe Motivational Chess (MC) combines Motivational Interviewing with chess game. Volunteers are submitted to 10 sessions of 90 minutes, over three weeks (total 15 hours: 10 hours of chess practice and 5 hours of motivational interviewing). The Active Control (AC) group consists of ten structured activities using cardboard, paper, crayons, among others. Volunteers are submitted to 10 sessions of 90 minutes, over three weeks (total 15 hours: 10 hours of recreational activities and 5 hours of information about basic cognitive functions). | Behavioural | Motivational Chess & Active Control |
Primary outcome
Neuropsychological tests
Time frame: three weeks
Trail Making Test, Stroop Color Test, Wisconsin Card Sorting Test, Behavioral Assessment of the Dysexecutive Syndrome, Digit Span Test, Iowa Gambling Test, Spatial Addition (Wechsler Memory Scale), Frontal Assessment Battery, Rey Complex Figure.
1 secondary outcome
Psychopathological rating scales
Time frame: three weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Results publication: PubMed 24913200Goncalves PD, Ometto M, Bechara A, Malbergier A, Amaral R, Nicastri S, Martins PA, Beraldo L, dos Santos B, Fuentes D, Andrade AG, Busatto GF, Cunha PJ. Motivational interviewing combined with chess accelerates improvement in executive functions in cocaine dependent patients: a one-month prospective study. Drug Alcohol Depend. 2014 Aug 1;141:79-84. doi: 10.1016/j.drugalcdep.2014.05.006. Epub 2014 May 24.
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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.
Arthur G de Andrade, M.D., Ph.D principal investigator
Program of the Interdisciplinary Group of Studies on Alcohol and Drugs (GREA), School of Medicine, Institute and Department of Psychiatry, University of Sao Paulo - USP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Chess in people with Cocaine Dependence, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 May 2016. 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 Brazil. 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. 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?
Results are not available in the source record.
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?
Neuropsychological tests (time frame: three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01914835, which also lists 1 linked publication.
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 26 May 2016.