Cocaine DependencePhase 2TMSCOCAINENCT01397266
Study of the Effect of Magnetic Stimulation Repetitive Transcranial on Impulsivity in Cocaine Dependence
A Phase 2 study testing Transcranial Magnetic Stimulation in people with Cocaine Dependence, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
In a randomized, double-blind controlled trial the investigators will evaluate the efficacy of rTMS in reducing impulsivity for cocaine addicts through - Quantitative and qualitative analysis - such behavior and possible behavioral consequences related. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2010to Jul 2013
- Phase
- Phase 2
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of the cocaine dependence syndrome, alone or in combination with abuse of alcohol and nicotine dependence (DSM IV, 1994; SCID-P, 1994).
- 20 days or less withdrawal
- 18-35 years old.
- If female, to be using contraception (barrier, oral contraceptive, IUD, surgical sterilization).
- Fixed residential address in Sao Paulo
Who cannot join
- Other Mental Disorders (DSM IV, 1994; SCID-P, 1994).
- organic brain disease, neurosurgery to implant metal clip or epilepsy.
- severe uncontrolled clinical comorbidity.
- use current or within last six months of psychotropic drugs in general, except for Clonazepam dose of up to four mg / day.
- Changes clinically significant laboratory findings. 13
- Condition or situation to which in the opinion of the investigator put the patient at risk significant, which may confound the results, or interfere substantially in individual's participation in the study.
- Mandate that mandating the judicial treatment for cocaine dependence
Trial locations and contacts
1 site in 1 country.
Ádan Jardim contact
Brazil1 site, 1 recruiting
- Recruiting
Department and Institute of Psychiatry, General Hospital, University of São Paulo Medical School
São Paulo, São Paulo
Ádan P JArdim, 55 11 30698159
Ádan P Jardim
About this study
Official title: Effect of Magnetic Stimulation Repetitive Transcranial on Impulsivity in Cocaine Dependence.
In a randomized, double-blind controlled trial the investigators will evaluate the efficacy of rTMS in reducing impulsivity for cocaine addicts through - Quantitative and qualitative analysis - such behavior and possible behavioral consequences related.
Read the detailed description
reduction of the rating impulsivity
- Conditions
- Cocaine Dependence
- Being tested
- Transcranial Magnetic Stimulation, Placebo TMS
- Keywords
- Transcranial Magnetic Stimulation, Cocaine, impulsivity, rating scale
- Medical subject headings
- Cocaine-Related Disorders, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationProcedure or surgery
Also called TMS
ACTIVE rTMS delivered to the left dorsolateral prefrontal cortex
Placebo TMSProcedure or surgery
Also called TMS
PLACEBO rTMS delivered to the left dorsolateral prefrontal cortex
| Study group | Role | What they receive |
|---|---|---|
| Active TMS | Active comparator | active rTMS delivered to the left dorsolateral prefrontal cortex Receives: Procedure: Transcranial Magnetic Stimulation |
| Placebo TMS | Placebo comparator | PLACEBO rTMS delivered to the left dorsolateral prefrontal cortex Receives: Procedure: Placebo TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Short PROMIS Questionnaire
The SPQ is a 160-question paper that counsellors and researchers can use to measure an individual's level of addictive tendency in each of sixteen distinct behavioural areas. Will be applied at the following times:
T0 (weeks 0 - immediately prior to the rTMS) T1 (4 weeks, after four weeks of treatment with rTMS) and T2 (8 weeks, four weeks after completing treatment).
The improvement rate of 10% or more, will be our primary measure of efficacy. T0 (
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startMar 2010
- Primary completionJan 2012 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Adan Jardim, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397266
- Sponsor's protocol ID
- 1339/09
- Acronym
- TMSCOCAINE
- Status last verified
- Aug 2010
- First submitted
- 13 May 2011
- Last updated
- 19 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnetic Stimulation Repetitive Transcranial on Impulsivity in Cocaine Dependence.
- ClinicalTrials.gov ID
- NCT01397266
- Acronym / sponsor ID
- TMSCOCAINE / 1339/09
- Conditions
- Cocaine Dependence
- Keywords
- Transcranial Magnetic Stimulation, Cocaine, impulsivity, rating scale
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 19 Jul 2011 (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.
In a randomized, double-blind controlled trial the investigators will evaluate the efficacy of rTMS in reducing impulsivity for cocaine addicts through - Quantitative and qualitative analysis - such behavior and possible behavioral consequences related.
Detailed description
reduction of the rating impulsivity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TMS | Active comparator | Procedure: Transcranial Magnetic Stimulationactive rTMS delivered to the left dorsolateral prefrontal cortex |
| Placebo TMS | Placebo comparator | Procedure: Placebo TMSPLACEBO rTMS delivered to the left dorsolateral prefrontal cortex |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of the cocaine dependence syndrome, alone or in combination with abuse of alcohol and nicotine dependence (DSM IV, 1994; SCID-P, 1994).
- 20 days or less withdrawal
- 18-35 years old.
- If female, to be using contraception (barrier, oral contraceptive, IUD, surgical sterilization).
- Fixed residential address in Sao Paulo
Key exclusion criteria (7 listed)
- Other Mental Disorders (DSM IV, 1994; SCID-P, 1994).
- organic brain disease, neurosurgery to implant metal clip or epilepsy.
- severe uncontrolled clinical comorbidity.
- use current or within last six months of psychotropic drugs in general, except for Clonazepam dose of up to four mg / day.
- Changes clinically significant laboratory findings. 13
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 |
|---|---|---|
| Transcranial Magnetic StimulationAlso: TMSACTIVE rTMS delivered to the left dorsolateral prefrontal cortex | Procedure or surgery | Active TMS |
| Placebo TMSAlso: TMSPLACEBO rTMS delivered to the left dorsolateral prefrontal cortex | Procedure or surgery | Placebo TMS |
Primary outcome
The Short PROMIS Questionnaire
Time frame: 2 months
The SPQ is a 160-question paper that counsellors and researchers can use to measure an individual's level of addictive tendency in each of sixteen distinct behavioural areas. Will be applied at the following times: T0 (weeks 0 - immediately prior to the rTMS) T1 (4 weeks, after four weeks of treatment with rTMS) and T2 (8 weeks, four weeks after completing treatment). The improvement rate of 10% or more, will be our primary measure of efficacy. T0 (
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2011.
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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.
Ádan Jardim contact
Adan Jardim principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transcranial Magnetic Stimulation 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 5 inclusion and 7 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 19 Jul 2011. 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Ádan Jardim (+551130698159), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Short PROMIS Questionnaire (time frame: 2 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 19 Jul 2011.