AzTrials
AzTrials

Cocaine AddictionPhase 2TMSCOCDEPENDNCT01259362

Effects of Repeated Transcranial Magnetic Stimulation (rTMS) on the Treatment of Cocaine Addicted Patients

A Phase 2 study testing Transcranial Magnetic Stimulation in people with Cocaine Addiction and Treatment, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Cocaine addiction is a serious disease. Nowadays we still have no efficient method reducing craving and extending the abstinence period of this patients during treatment. The aim of this study is to evaluate reduction if craving and other parameters related to addiction within this group of patients through a… Read more about this study

Who is it for?
Ages 18 to 40 years
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
40 participants
Where
1 siteBrazil
Study dates
Mar 2010to Jul 2012
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 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Minimum age of 18
  • Maximum age of 40
  • Diagnostic of Cocaine addiction
  • Willingly participate the study

Who cannot join

  • Metallic Cerebral Implant
  • History of Severe Brain trauma or injury
  • Organic Brain Disease
  • Severe Somatic Disease
  • History of other actual or past psychiatric diagnostics

Trial locations and contacts

1 site in 1 country.

Philip L Ribeiro, MD contact

551130698159

philipribeiro@usp.br

Brazil1 site, 1 recruiting

  • Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school

    São Paulo, São Paulo, 05403010

    Philip L Ribeiro, md, 551130698159, philipribeiro@usp.br

    Philip L Ribeiro, MD

    Recruiting

Other trials in Brazil

About this study

Official title: Efeitos da Estimulacao Magnetica Transcrania de Repeticao ( EMTr) no Tratamento da Dependencia ao Uso de Cocaina

Cocaine addiction is a serious disease. Nowadays we still have no efficient method reducing craving and extending the abstinence period of this patients during treatment.

The aim of this study is to evaluate reduction if craving and other parameters related to addiction within this group of patients through a treatment with transcranial magnetic stimulation.

Read the detailed description

Patients are going to submitted do a course of rTMS of one month, each session up to 15 minutes.

After the rTMS they are going to be offered cognitive therapy to prevent relapse.

The area stimulated is the dorso-lateral prefrontal cortex. This technique was employed in previous studies and the risks are insignificant.

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.

  • Transcranial Magnetic StimulationProcedure or surgery

    Also called rTMS, Cocaine Addiction, Cocaine Addiction Treatment

    5 Hz, 120 % motor threshold, intertrain interval 20s, number of pulses in train 50.

  • Transcranial Magnetic StimulationProcedure or surgery

    Also called TMS, Cocaine Addiction, Sham Stimulation

    Cocaine addicted will receive 20 sham TMSr

Study groups in NCT01259362
Study groupRoleWhat they receive
Transcranial Magnetic StimulationActive comparatorCocaine addicted will receive a 20 day TMSr to right dorsolateral prefrontal cortex.
Receives: Procedure: Transcranial Magnetic Stimulation
Transcranial Magnetic StimlationSham comparatorcocaine addicted will receive a 20 day sham TMSr to right dorsolateral prefrontal cortex
Receives: Procedure: Transcranial Magnetic Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Minnesota Cocaine Craving Scale(MCCS)

    Reduction on the scores of MCCS

    Measured: 2 months

Secondary outcomes (1)

  1. Barrat Impulsiveness Scale vers 11 ( BIS 11)

    Reduction of scores of BIS 11.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionMar 2012 (estimated)
  4. Study completionJul 2012 (estimated)

Resources

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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01259362
Sponsor's protocol ID
PLRIBEIRO1
Acronym
TMSCOCDEPEND
Status last verified
Sep 2010
First submitted
10 Dec 2010
Last updated
22 Dec 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Transcranial Magnetic Stimulation in people with Cocaine Addiction and Treatment, 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 5 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 22 Dec 2010. 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 Philip L Ribeiro, MD (551130698159, philipribeiro@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Minnesota Cocaine Craving Scale(MCCS) (time frame: 2 months). 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 NCT01259362.

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 22 Dec 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in