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Prefrontal Cortex Stimulation as Treatment for Crack-cocaine Addiction

Primary Purpose

Cocaine Addiction, Cocaine-related Disorder, Executive Dysfunction

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
transcranial Direct Current Stimulation
Sponsored by
Federal University of Espirito Santo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Addiction focused on measuring crack cocaine, addiction, tDCS, ERP, P300, attention, inhibitory control, working memory

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

sham-tDCS

active-tDCS

Arm Description

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.

low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex

Outcomes

Primary Outcome Measures

Abstinence
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.

Secondary Outcome Measures

Intensity of the Urge to the Use of Crack-cocaine
The intensity of craving will be examined by a short scale, the Brief Cocaine Craving Questionnaire.
Event Related Potentials
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.
Cognitive Tests
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.
State of Depression
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.

Full Information

First Posted
April 14, 2011
Last Updated
December 23, 2013
Sponsor
Federal University of Espirito Santo
Collaborators
Harvard University, University of Göttingen
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1. Study Identification

Unique Protocol Identification Number
NCT01337297
Brief Title
Prefrontal Cortex Stimulation as Treatment for Crack-cocaine Addiction
Official Title
Treatment of Crack-cocaine Addiction Through Cognitive Neuromodulation of the Prefrontal Cortex Produced by Transcranial Direct Current Stimulation.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Espirito Santo
Collaborators
Harvard University, University of Göttingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Addiction, Cocaine-related Disorder, Executive Dysfunction
Keywords
crack cocaine, addiction, tDCS, ERP, P300, attention, inhibitory control, working memory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sham-tDCS
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
active-tDCS
Arm Type
Experimental
Arm Description
low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex
Intervention Type
Device
Intervention Name(s)
transcranial Direct Current Stimulation
Other Intervention Name(s)
brain stimulation, non-invasive brain stimulation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Abstinence
Description
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.
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.
Secondary Outcome Measure Information:
Title
Intensity of the Urge to the Use of Crack-cocaine
Description
The intensity of craving will be examined by a short scale, the Brief Cocaine Craving Questionnaire.
Time Frame
before and after ERP in two weekly sessions over two weeks
Title
Event Related Potentials
Description
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.
Time Frame
twice a week over two consecutive weeks during the treatment
Title
Cognitive Tests
Description
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.
Time Frame
Before the first experimental session, in the middle of the protocol and two days after the last experimental session
Title
State of Depression
Description
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.
Time Frame
Before the first experimental session, in the middle of the treatment and after the last experimental session.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ester M Nakamura-Palacios, MD, PhD
Organizational Affiliation
Federal University of Espírito Santo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Cognitive Sciences and Neuropsychopharmacology, Post-Graduation Program in Physiologycal Sciences, Health Sciences Center, Federal University of Espírito Santo
City
Vitória
State/Province
Espírito Santo
ZIP/Postal Code
29042-755
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
12927659
Citation
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Results Reference
derived

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Prefrontal Cortex Stimulation as Treatment for Crack-cocaine Addiction

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