Prefrontal Cortex Stimulation as Treatment for Crack-cocaine Addiction - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cocaine Addiction Cocaine-related Disorder Executive Dysfunction	Device: transcranial Direct Current Stimulation	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Treatment of Crack-cocaine Addiction Through Cognitive Neuromodulation of the Prefrontal Cortex Produced by Transcranial Direct Current Stimulation.

Resource links provided by NLM:

Drug Information available for: Cocaine hydrochloride

U.S. FDA Resources

Further study details as provided by Federal University of Espirito Santo:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]
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 [ Time Frame: before and after ERP in two weekly sessions over two weeks ] [ Designated as safety issue: No ]
The intensity of craving will be examined by a short scale, the Brief Cocaine Craving Questionnaire.
Event Related Potentials [ Time Frame: twice a week over two consecutive weeks during the treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: Before the first experimental session, in the middle of the protocol and two days after the last experimental session ] [ Designated as safety issue: No ]
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 [ Time Frame: Before the first experimental session, in the middle of the treatment and after the last experimental session. ] [ Designated as safety issue: No ]
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.


Enrollment:	20
Study Start Date:	June 2011
Study Completion Date:	May 2013
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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: brain stimulation non-invasive 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: brain stimulation non-invasive brain stimulation

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.

Eligibility


Ages Eligible for Study:	18 Years to 60 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337297

Locations


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

Sponsors and Collaborators

Federal University of Espirito Santo

Harvard University

University of Göttingen

Investigators


Principal Investigator:	Ester M Nakamura-Palacios, MD, PhD	Federal University of Espírito Santo

More Information

Publications:

Aharonovich E, Nunes E, Hasin D. Cognitive impairment, retention and abstinence among cocaine abusers in cognitive-behavioral treatment. Drug Alcohol Depend. 2003 Aug 20;71(2):207-11.

Aharonovich E, Hasin DS, Brooks AC, Liu X, Bisaga A, Nunes EV. Cognitive deficits predict low treatment retention in cocaine dependent patients. Drug Alcohol Depend. 2006 Feb 28;81(3):313-22. Epub 2005 Sep 19.

Boggio PS, Sultani N, Fecteau S, Merabet L, Mecca T, Pascual-Leone A, Basaglia A, Fregni F. Prefrontal cortex modulation using transcranial DC stimulation reduces alcohol craving: a double-blind, sham-controlled study. Drug Alcohol Depend. 2008 Jan 1;92(1-3):55-60. Epub 2007 Jul 19.

Boggio PS, Rigonatti SP, Ribeiro RB, Myczkowski ML, Nitsche MA, Pascual-Leone A, Fregni F. A randomized, double-blind clinical trial on the efficacy of cortical direct current stimulation for the treatment of major depression. Int J Neuropsychopharmacol. 2008 Mar;11(2):249-54. Epub 2007 Jun 11.

Dubois B, Slachevsky A, Litvan I, Pillon B. The FAB: a Frontal Assessment Battery at bedside. Neurology. 2000 Dec 12;55(11):1621-6.

Franco GM. [The cognitive potential in normal adults]. Arq Neuropsiquiatr. 2001 Jun;59(2-A):198-200. Portuguese.

Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98.

Fregni F, Boggio PS, Nitsche M, Bermpohl F, Antal A, Feredoes E, Marcolin MA, Rigonatti SP, Silva MT, Paulus W, Pascual-Leone A. Anodal transcranial direct current stimulation of prefrontal cortex enhances working memory. Exp Brain Res. 2005 Sep;166(1):23-30. Epub 2005 Jul 6.

HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23:56-62.

Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Conti CL, Nakamura-Palacios EM. Bilateral transcranial direct current stimulation over dorsolateral prefrontal cortex changes the drug-cued reactivity in the anterior cingulate cortex of crack-cocaine addicts. Brain Stimul. 2014 Jan-Feb;7(1):130-2. doi: 10.1016/j.brs.2013.09.007. Epub 2013 Oct 12.


Responsible Party:	Ester Miyuki Nakamura-Palacios, MD, PhD, Federal University of Espirito Santo
ClinicalTrials.gov Identifier:	NCT01337297 History of Changes
Other Study ID Numbers:	CEP-UFES 296/10
Study First Received:	April 14, 2011
Results First Received:	September 24, 2013
Last Updated:	December 23, 2013
Health Authority:	Brazil: Ethics Committee

Keywords provided by Federal University of Espirito Santo:


crack cocaine addiction tDCS ERP	P300 attention inhibitory control working memory

Additional relevant MeSH terms:


Behavior, Addictive Cocaine-Related Disorders Compulsive Behavior Impulsive Behavior Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Cocaine Anesthetics, Local Anesthetics Central Nervous System Depressants	Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Vasoconstrictor Agents Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 23, 2016