Prefrontal Cortex Stimulation as Treatment for Crack-cocaine Addiction

December 23, 2013 updated by: Ester Miyuki Nakamura-Palacios, Federal University of Espirito Santo

Treatment of Crack-cocaine Addiction Through Cognitive Neuromodulation of the Prefrontal Cortex Produced by Transcranial Direct Current Stimulation.

The use of crack-cocaine is growing at alarming rate in our country and it is absolutely worrisome the fast establishment of addiction to it. Its immediate effects, that are intense and extremely fleeting, increase dramatically the probability of this drug to be consumed again, settling quickly down the loss of control and the compulsive use, turning the effects of this drug highly addictive. Parallel to this process, brain damages are quickly established, progressing to severe impairments of frontal functions, leading to the lack of cognitive control that feeds back and aggravates the dependence, and hampers any therapeutic approach. The existing treatments have not proved to be satisfactory yet. Thus, considering that a new modality of treatment, based on the neuromodulation induced by noninvasive brain stimulation, has been useful in treating various neuropsychiatric conditions, this study will examine the potential beneficial effects of repeated transcranial Direct Current Stimulation over the left dorsolateral prefrontal cortex in the treatment of crack-cocaine addiction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Forty subjects between 18 and 60 years old, both genders, with a diagnosis of dependence on crack-cocaine, evaluated for the first time at the Center for Psychosocial Care for Alcohol and Other Drugs (CAPS-AD, in Portuguese) in the municipality of Serra, ES, Brazil, will be invited to participate in this study. After triage, following the inclusion and exclusion criteria, they will be informed in details about the experimental protocol and, if they agree to participate, it will be required to sign an Informed Consent. It Will be applied a structured anamnesis, made a psychiatric clinical and physical examination. The treatment will be started with regular medications for abstinence and comorbidities and psychosocial approaches usually done in the CAPS-AD. After selected they will be referred to the Laboratory of Cognitive Science and Neuropsychopharmacology of the Postgraduate Program in Physiological Sciences from Health Sciences Center of Federal University of Espírito Santo where they will be semi-randomly (matched for age, gender and sociodemographic characteristics) distributed into two different groups: (A) sham-tDCS (n = 20) and (B) active-tDCS (n = 20); and they will follow for 10 applications in daily sessions, excepting on weekends, of transcranial direct current stimulation (tDCS, 5 x 7 cm2, 2 mA, 20 min) over the left dorsolateral prefrontal cortex or sham procedure. Event-related potentials (ERP) will be recorded before, during and after brain stimulation or sham procedure under random presentation of three related images and three non-related images to crack use. The compulsive behavior will be evaluated before and after the ERP records. Cognitive tests which assess mental function, frontal function, visuospatial and verbal working memory, inhibition, and conflict resolution will be performed. The depression will be assessed during the treatment, and the addicted subjects will be evaluated once a week for four consecutive weeks after a series of applications of sham-tDCS or active-tDCS.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29042-755
        • Laboratory of Cognitive Sciences and Neuropsychopharmacology, Post-Graduation Program in Physiologycal Sciences, Health Sciences Center, Federal University of Espírito Santo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • fulfill the criteria for the crack-dependence syndrome, based on criteria of the International Classification of Diseases on its 10th version;
  • all users and addicts who make use of crack-cocaine alone or in combination with other drugs (alcohol, nicotine, caffeine, cannabis, etc.), or who have psychiatric comorbidities (anxiety, depression, etc.)
  • must be clinically stable and not requiring hospitalization;
  • should be clinically suitable for the treatment proposed in this study;
  • need to be able to read, write and speak Portuguese

Exclusion Criteria:

  • should not present current or past illnesses that may be aggravated during treatment;
  • may not show abnormalities in laboratory tests which suggest a deterioration of its physical condition for participation in the study;
  • individuals who have some metal in the brain or skull (chips, fragments, pins, etc. - except titanium);
  • history of epilepsy, severe brain trauma, cochlear implant, cardiac pacemaker or intracardiac metal apparatus);
  • pregnants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: sham-tDCS
the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session.
Device: transcranial Direct Current Stimulation
transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site).
Other Names:
  • non-invasive brain stimulation
  • brain stimulation
EXPERIMENTAL: active-tDCS
low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex
Device: transcranial Direct Current Stimulation
transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site).
Other Names:
  • non-invasive brain stimulation
  • brain stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abstinence
Time Frame: Two days after the end of tDCS treatment (one session every other day, 5 sessions), that is, on the 12nd day from the beginning.
abstinence to the use of crack-cocaine up to 3 months after the completion of two-weeks of treatment sessions with active-tDCS or sham-tDCS.
Two days after the end of tDCS treatment (one session every other day, 5 sessions), that is, on the 12nd day from the beginning.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity of the Urge to the Use of Crack-cocaine
Time Frame: before and after ERP in two weekly sessions over two weeks
The intensity of craving will be examined by a short scale, the Brief Cocaine Craving Questionnaire.
before and after ERP in two weekly sessions over two weeks
Event Related Potentials
Time Frame: twice a week over two consecutive weeks during the treatment
Event Related Potentials (ERPs) elicited by random presentation of three related images and three non-related images to crack use every Monday and Friday over the two-weeks period of active-tDCS or sham-tDCS.
twice a week over two consecutive weeks during the treatment
Cognitive Tests
Time Frame: Before the first experimental session, in the middle of the protocol and two days after the last experimental session
Cognitive tests are comprised by frontal assessment battery (FAB), Mini-Mental Status Examination (MMSE), verbal n-back task, visuospatial n-back task, go/no-go test.
Before the first experimental session, in the middle of the protocol and two days after the last experimental session
State of Depression
Time Frame: Before the first experimental session, in the middle of the treatment and after the last experimental session.
It will be applied Hamilton Scale for Depression, a structured multiple choice questionnaire used to assess the severity of the symptoms of depression. It will be applied with cognitive tests.
Before the first experimental session, in the middle of the treatment and after the last experimental session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Espirito Santo

Collaborators

Harvard University
University of Göttingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

April 14, 2011

First Submitted That Met QC Criteria

April 15, 2011

First Posted (ESTIMATE)

April 18, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 30, 2014

Last Update Submitted That Met QC Criteria

December 23, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP-UFES 296/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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