search
Back to results

Bilateral Prefrontal Modulation in Crack-cocaine Addiction (tDCS_CRACK)

Primary Purpose

Drug Addiction, Executive Dysfunction

Status
Completed
Phase
Phase 2
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 Drug Addiction focused on measuring crack-cocaine addiction, tDCS, dlPFC, craving, cognition

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients between the age of 18 and 60 years;
  • met criteria for crack-cocaine dependence according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), as determined by clinical evaluation;
  • in stable clinical condition with no need for inpatient care;
  • able to read, write, and speak Portuguese; and
  • no severe withdrawal signs or symptoms at baseline.

Exclusion Criteria:

  • a condition of intoxication or withdrawal due to a substance other than crack-cocaine;
  • unstable mental or medical disorder or substance abuse or addiction other than crack-cocaine dependence, except nicotine and/or caffeine;
  • a diagnosis of epilepsy, convulsions;
  • a previous history of drug hypersensitivity or adverse reactions to diazepam or other benzodiazepines and haloperidol;
  • any contraindication for electrical brain stimulation procedures such as electronic implants or metal implants;
  • suspected pregnancy for female participants;

Sites / Locations

  • Federal University of Espírito Santo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

real tDCS

sham-tDCS

Arm Description

Ten sessions (every other day) of bilateral transcranial Direct Current Stimulation (tDCS: 2 milliamperes, 3 x 7 cm2, during 20 minutes) over dorsolateral Prefrontal Cortex (cathodal left / anodal right).

Ten sessions (every other day) of placebo control (sham procedure) of transcranial Direct Current Stimulation (sham-tDCS) during 20 minutes with electrodes placed over the dorsolateral Prefrontal Cortex (cathodal left / anodal right). Current was delivered for 30 seconds and was turned off for the rest of the stimulation period. In this way, subjects experienced the initial itching sensation at the beginning of stimulation, but received no current for the rest of the session.

Outcomes

Primary Outcome Measures

Craving
Five items from the original obsessive compulsive drinking scale, which are believed to reliably assess craving in a narrow sense were used. Questions of this brief scale allow quantification of thoughts and feelings (obsessions), and behavioral intentions, and are answered on a scale ranging from 0 to 4, resulting in a total score between 0 and 20. Higher scores reflect more severe craving. These items were applied at the beginning, during and at the end of the treatment with sham-tDCS or tDCS.
Relapses
A use relapse was defined as the first episode of return to the previous uncontrolled pattern of crack-cocaine use (rocks per day). Information about relapse were gathered directly when patients regularly returned to the hospital for clinical follow-up after their discharge and/or by self-report or reports of family members by telephone calls.

Secondary Outcome Measures

Full Information

First Posted
March 16, 2014
Last Updated
March 29, 2019
Sponsor
Federal University of Espirito Santo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Harvard Medical School (HMS and HSDM), University of Göttingen
search

1. Study Identification

Unique Protocol Identification Number
NCT02091167
Brief Title
Bilateral Prefrontal Modulation in Crack-cocaine Addiction
Acronym
tDCS_CRACK
Official Title
Prefrontal Modulation by Repetitive Bilateral Transcranial Direct Current Stimulation (tDCS) in Crack-cocaine Addicted Inpatients.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Espirito Santo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Harvard Medical School (HMS and HSDM), University of Göttingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study, eligible crack-cocaine addicted inpatients recruited from specialized clinics for substance abuse disorder treatment, filling inclusion criteria and not showing any exclusion criteria, were randomized to receive the repetitive (10 sessions, every other day) bilateral dorsolateral Prefrontal Cortex (dlPFC: cathodal left / anodal right) tDCS (2 milliamperes, 3x7 cm2, for 20 min) or placebo (sham-tDCS). Craving to the use of crack-cocaine was examined before (baseline), during and after the end of the tDCS treatment. Based in our previous data, our hypothesis was that repetitive bilateral tDCS over dlPFC would favorably change clinical, cognitive and brain function in crack-cocaine addiction and these would be long-lasting effects.
Detailed Description
Before (baseline) and after tDCS or sham-tDCS treatment, subjects were examined: (1) clinically, regarding craving (obsessive compulsive scale) and relapses to the drug use. They were followed-up for clinical examination at least 60 days after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Addiction, Executive Dysfunction
Keywords
crack-cocaine addiction, tDCS, dlPFC, craving, cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Sham-controlled double-blind randomized clinical trial
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
real tDCS
Arm Type
Experimental
Arm Description
Ten sessions (every other day) of bilateral transcranial Direct Current Stimulation (tDCS: 2 milliamperes, 3 x 7 cm2, during 20 minutes) over dorsolateral Prefrontal Cortex (cathodal left / anodal right).
Arm Title
sham-tDCS
Arm Type
Sham Comparator
Arm Description
Ten sessions (every other day) of placebo control (sham procedure) of transcranial Direct Current Stimulation (sham-tDCS) during 20 minutes with electrodes placed over the dorsolateral Prefrontal Cortex (cathodal left / anodal right). Current was delivered for 30 seconds and was turned off for the rest of the stimulation period. In this way, subjects experienced the initial itching sensation at the beginning of stimulation, but received no current for the rest of the session.
Intervention Type
Device
Intervention Name(s)
transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS
Intervention Description
Direct currents are transferred via a pair of carbonated-silicone electrodes (35 cm2) with a thick layer of high conductive gel for EEG underneath them. The electric current is delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode is placed over F3 according to the 10-20 international system while the anode is placed over the contralateral F4 region. The currents flows continuously for 20 minutes with an intensity of 2 milliamperes.
Primary Outcome Measure Information:
Title
Craving
Description
Five items from the original obsessive compulsive drinking scale, which are believed to reliably assess craving in a narrow sense were used. Questions of this brief scale allow quantification of thoughts and feelings (obsessions), and behavioral intentions, and are answered on a scale ranging from 0 to 4, resulting in a total score between 0 and 20. Higher scores reflect more severe craving. These items were applied at the beginning, during and at the end of the treatment with sham-tDCS or tDCS.
Time Frame
Five applications: once in the week before tDCS treatment (baseline), second, third and fourth weeks, during the treatment, and in the fith week, after the end of the tDCS treatment.
Title
Relapses
Description
A use relapse was defined as the first episode of return to the previous uncontrolled pattern of crack-cocaine use (rocks per day). Information about relapse were gathered directly when patients regularly returned to the hospital for clinical follow-up after their discharge and/or by self-report or reports of family members by telephone calls.
Time Frame
30 and 60 days after discharge from clinics

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients between the age of 18 and 60 years; met criteria for crack-cocaine dependence according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), as determined by clinical evaluation; in stable clinical condition with no need for inpatient care; able to read, write, and speak Portuguese; and no severe withdrawal signs or symptoms at baseline. Exclusion Criteria: a condition of intoxication or withdrawal due to a substance other than crack-cocaine; unstable mental or medical disorder or substance abuse or addiction other than crack-cocaine dependence, except nicotine and/or caffeine; a diagnosis of epilepsy, convulsions; a previous history of drug hypersensitivity or adverse reactions to diazepam or other benzodiazepines and haloperidol; any contraindication for electrical brain stimulation procedures such as electronic implants or metal implants; suspected pregnancy for female participants;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ester MN Palacios, MD, PhD
Organizational Affiliation
Federal University of Espírito Santo
Official's Role
Study Director
Facility Information:
Facility Name
Federal University of Espírito Santo
City
Vitória
State/Province
ES - Espírito Santo
ZIP/Postal Code
29060-720
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24139147
Citation
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.
Results Reference
background
PubMed Identifier
23891741
Citation
da Silva MC, Conti CL, Klauss J, Alves LG, do Nascimento Cavalcante HM, Fregni F, Nitsche MA, Nakamura-Palacios EM. Behavioral effects of transcranial direct current stimulation (tDCS) induced dorsolateral prefrontal cortex plasticity in alcohol dependence. J Physiol Paris. 2013 Dec;107(6):493-502. doi: 10.1016/j.jphysparis.2013.07.003. Epub 2013 Jul 25.
Results Reference
background
PubMed Identifier
24256621
Citation
Nakamura-Palacios EM, Souza RS, Zago-Gomes MP, de Melo AM, Braga FS, Kubo TT, Gasparetto EL. Gray matter volume in left rostral middle frontal and left cerebellar cortices predicts frontal executive performance in alcoholic subjects. Alcohol Clin Exp Res. 2014 Apr;38(4):1126-33. doi: 10.1111/acer.12308. Epub 2013 Nov 20.
Results Reference
background
PubMed Identifier
22878259
Citation
de Souza Custodio JC, Martins CW, Lugon MD, Fregni F, Nakamura-Palacios EM. Epidural direct current stimulation over the left medial prefrontal cortex facilitates spatial working memory performance in rats. Brain Stimul. 2013 May;6(3):261-9. doi: 10.1016/j.brs.2012.07.004. Epub 2012 Aug 1.
Results Reference
background
PubMed Identifier
26065432
Citation
Batista EK, Klauss J, Fregni F, Nitsche MA, Nakamura-Palacios EM. A Randomized Placebo-Controlled Trial of Targeted Prefrontal Cortex Modulation with Bilateral tDCS in Patients with Crack-Cocaine Dependence. Int J Neuropsychopharmacol. 2015 Jun 10;18(12):pyv066. doi: 10.1093/ijnp/pyv066.
Results Reference
background
PubMed Identifier
27138429
Citation
Nakamura-Palacios EM, Lopes IB, Souza RA, Klauss J, Batista EK, Conti CL, Moscon JA, de Souza RS. Ventral medial prefrontal cortex (vmPFC) as a target of the dorsolateral prefrontal modulation by transcranial direct current stimulation (tDCS) in drug addiction. J Neural Transm (Vienna). 2016 Oct;123(10):1179-94. doi: 10.1007/s00702-016-1559-9. Epub 2016 Apr 30.
Results Reference
background
PubMed Identifier
30018558
Citation
Klauss J, Anders QS, Felippe LV, Nitsche MA, Nakamura-Palacios EM. Multiple Sessions of Transcranial Direct Current Stimulation (tDCS) Reduced Craving and Relapses for Alcohol Use: A Randomized Placebo-Controlled Trial in Alcohol Use Disorder. Front Pharmacol. 2018 Jul 3;9:716. doi: 10.3389/fphar.2018.00716. eCollection 2018.
Results Reference
background
PubMed Identifier
30050442
Citation
de Souza Custodio JC, Martins CW, Lugon MDMV, de Melo Rodrigues LC, de Figueiredo SG, Nakamura-Palacios EM. Prefrontal BDNF Levels After Anodal Epidural Direct Current Stimulation in Rats. Front Pharmacol. 2018 Jul 12;9:755. doi: 10.3389/fphar.2018.00755. eCollection 2018.
Results Reference
background
PubMed Identifier
25008145
Citation
Klauss J, Penido Pinheiro LC, Silva Merlo BL, de Almeida Correia Santos G, Fregni F, Nitsche MA, Miyuki Nakamura-Palacios E. A randomized controlled trial of targeted prefrontal cortex modulation with tDCS in patients with alcohol dependence. Int J Neuropsychopharmacol. 2014 Nov;17(11):1793-803. doi: 10.1017/S1461145714000984. Epub 2014 Jul 10.
Results Reference
background
PubMed Identifier
30405417
Citation
Anders QS, Klauss J, Rodrigues LCM, Nakamura-Palacios EM. FosB mRNA Expression in Peripheral Blood Lymphocytes in Drug Addicted Patients. Front Pharmacol. 2018 Oct 24;9:1205. doi: 10.3389/fphar.2018.01205. eCollection 2018.
Results Reference
background
PubMed Identifier
30654123
Citation
Martins CW, de Melo Rodrigues LC, Nitsche MA, Nakamura-Palacios EM. AMPA receptors are involved in prefrontal direct current stimulation effects on long-term working memory and GAP-43 expression. Behav Brain Res. 2019 Apr 19;362:208-212. doi: 10.1016/j.bbr.2019.01.023. Epub 2019 Jan 14.
Results Reference
background
PubMed Identifier
30405414
Citation
Klauss J, Anders QS, Felippe LV, Ferreira LVB, Cruz MA, Nitsche MA, Nakamura-Palacios EM. Lack of Effects of Extended Sessions of Transcranial Direct Current Stimulation (tDCS) Over Dorsolateral Prefrontal Cortex on Craving and Relapses in Crack-Cocaine Users. Front Pharmacol. 2018 Oct 23;9:1198. doi: 10.3389/fphar.2018.01198. eCollection 2018.
Results Reference
result

Learn more about this trial

Bilateral Prefrontal Modulation in Crack-cocaine Addiction

We'll reach out to this number within 24 hrs