Prefrontal Cortex Stimulation as Treatment for Crack-cocaine Addiction

NCT01337297 | Completed Phase 1 Results

• 1 other identifier: CEP-UFES 296/10
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Addiction; Cocaine-related Disorder; Executive Dysfunction

Keywords

crack cocaine; addiction; tDCS; ERP; P300; attention; inhibitory control; working memory

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (4)

• Intensity of the Urge to the Use of Crack-cocaine

  before and after ERP in two weekly sessions over two weeks

• Event Related Potentials

  twice a week over two consecutive weeks during the treatment

• Cognitive Tests

  Before the first experimental session, in the middle of the protocol and two days after the last experimental session

• State of Depression

  Before the first experimental session, in the middle of the treatment and after the last experimental session.

Study Arms (2)

sham-tDCS

PLACEBO COMPARATOR

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

active-tDCS

EXPERIMENTAL

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

Device: transcranial Direct Current Stimulation

Interventions

transcranial Direct Current Stimulation DEVICE

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).

Also known as: brain stimulation, non-invasive brain stimulation

active-tDCS; sham-tDCS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Espirito Santo: lead
• Harvard University: collaborator
• University of Göttingen: collaborator

Study Sites (1)

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

Vitória, Espírito Santo, 29042-755, Brazil

Location

Related Publications (11)

• 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. doi: 10.1016/s0376-8716(03)00092-9.

  PMID: 12927659 BACKGROUND

• 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. doi: 10.1016/j.drugalcdep.2005.08.003. Epub 2005 Sep 19.

  PMID: 16171953 BACKGROUND

• 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. doi: 10.1016/j.drugalcdep.2007.06.011. Epub 2007 Jul 19.

  PMID: 17640830 BACKGROUND

• 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. doi: 10.1017/S1461145707007833. Epub 2007 Jun 11.

  PMID: 17559710 BACKGROUND

• Dubois B, Slachevsky A, Litvan I, Pillon B. The FAB: a Frontal Assessment Battery at bedside. Neurology. 2000 Dec 12;55(11):1621-6. doi: 10.1212/wnl.55.11.1621.

  PMID: 11113214 BACKGROUND

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

  PMID: 11400024 BACKGROUND

• 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. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

  PMID: 1202204 BACKGROUND

• 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. doi: 10.1007/s00221-005-2334-6. Epub 2005 Jul 6.

  PMID: 15999258 BACKGROUND

• HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.

  PMID: 14399272 BACKGROUND

• 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.

  PMID: 20633386 BACKGROUND

• 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.

  PMID: 24139147 DERIVED

MeSH Terms

Conditions

Cocaine-Related Disorders; Behavior, Addictive

Interventions

Transcranial Direct Current Stimulation; Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Surgical Procedures, Operative

Limitations and Caveats

Crack-cocaine is highly addictive, extremely difficult to treat and with high dropouts. 7 subjects started with anodal DLPFC tDCS showing high relapses (not shown). The remaining 13 subjects tested with bilateral DLPFC tDCS or sham were considered.

Results Point of Contact

• Title: Dr. Ester Miyuki Nakamura-Palacios
• Organization: Federal University of Espírito Santo

emnpalacios@gmail.com

+55 27 7775-7337

Study Officials

• Ester M Nakamura-Palacios, MD, PhD

  Federal University of Espírito Santo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 14, 2011
• First Posted: April 18, 2011
• Study Start: June 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: May 1, 2013
• Last Updated: January 30, 2014
• Results First Posted: November 27, 2013

Record last verified: 2013-12

Locations

BR (1)