Trial record 2 of 2 for:    Open Studies | "Crack Cocaine"

Bilateral Prefrontal Modulation in Crack-cocaine Addiction (tDCS_CRACK)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Federal University of Espirito Santo
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Harvard Medical School
University of Göttingen
Information provided by (Responsible Party):
Ester Miyuki Nakamura-Palacios, Federal University of Espirito Santo
ClinicalTrials.gov Identifier:
NCT02091167
First received: March 16, 2014
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

In this study, eligible crack-cocaine addicted inpatients recruited from a specialized clinic for addiction treatment, filling inclusion criteria and not showing any exclusion criteria, will be randomized to receive the repetitive (5 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 will be examined before (baseline), during and after the end of the tDCS treatment. Other clinical outcomes, and also visual P3 event-related potential and neuroimagings exams will be also performed before and after treatment.

Based in our previous data, our hypothesis is that repetitive bilateral tDCS over dlPFC will favorably change clinical, cognitive and brain function in crack-cocaine addiction and these will be long-lasting effects.


Condition Intervention Phase
Drug Addiction
Executive Dysfunction
Device: transcranial Direct Current Stimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prefrontal Modulation by Repetitive Bilateral Transcranial Direct Current Stimulation (tDCS) in Crack-cocaine Addicted Inpatients.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Changes on craving (adapted obsessive compulsive scale) [ Time Frame: Four applications: before tDCS treatment (baseline), first and second weeks, during the treatment, and in the third week, after the end of the tDCS treatment. ] [ Designated as safety issue: No ]
    Five items (1, 2, 4, 5, and 13) from the original obsessive compulsive drinking scale (Bohn et al., 1996), which are believed to reliably assess craving in a narrow sense (de Wildt et al., 2005; Furieri and Nakamura-Palacios, 2007) was adapted to crack-cocaine use. This items will be applied at the beginning, during and at the end of the treatment with sham-tDCS or tDCS.


Secondary Outcome Measures:
  • Changes on Frontal Assessment Battery (FAB) [ Time Frame: Before tDCS treatment (baseline) and after the end of the tDCS treatment (in the third week). ] [ Designated as safety issue: No ]
    The FAB, developed by Dubois et al. (2000) was used to explore the following six different domains of executive function: (1) conceptualization; (2) mental flexibility; (3) motor programming; (4) sensitivity to interference; (5) inhibitory control; (6) autonomy. Each of these items is scored from 0 (zero) to a maximum of 3. Thus, the maximum score of FAB is 18. A single well trained examiner administered this assessment. The instrument was carefully explained and pretrained shortly before its full application at the beginning and at the end of the five-week treatment.

  • Changes on Mini-Mental Status Examination (MMSE) [ Time Frame: Before tDCS treatment (baseline) and after the end of the tDCS treatment (in the third week). ] [ Designated as safety issue: No ]
    An adapted version of the MMSE in Portuguese was used. This version included an 11-item examination that examined five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score that could be achieved was 30, while a mean score between 23 and 26 or between 26 and 29 would be expected according to the age and educational level (Crum et al., 1993) of the alcoholics. The instrument was also explained and pre-trained shortly before its full application at the beginning and at the end of the five-week treatment.

  • Changes on Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Before tDCS treatment (baseline) and after the end of the tDCS treatment (in the third week). ] [ Designated as safety issue: No ]
    A structured multiple-choice questionnaire was used to assess the severity of depression symptoms. This instrument assesses the severity of symptoms observed in depression, such as low mood, insomnia, agitation, anxiety and weight loss (Hamilton, 1960). The examiner must choose between the possible answers to each question by interviewing the patient and by observing the patient's symptoms. Each question has between 3 and 5 possible answers that increase in severity. In the original scale, the first 17 questions contribute to the total score, while questions 18 to 21 provide additional information about depression (e.g., diurnal variation, paranoid symptoms), but are not included in the total score of the scale. This scale was applied at the beginning and at the end of the five-week treatment.

  • Changes on Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: Before tDCS treatment (baseline) and after the end of the tDCS treatment (in the third week). ] [ Designated as safety issue: No ]
    A structured multiple-choice questionnaire (Hamilton, 1959) designed to assess the severity of anxiety symptoms was employed. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (e.g., mental agitation and psychological distress) and somatic anxiety (e.g., physical complaints related to anxiety). This scale was also applied at the beginning and at the end of the five-week treatment.

  • Changes on quality of life of the World Health Organization (WHOQOL-BREF) [ Time Frame: Before tDCS treatment (baseline) and after the end of the tDCS treatment (in the third week). ] [ Designated as safety issue: No ]
    An abbreviated instrument of cross-culturally valid assessment of quality of life of the World Health Organization (WHOQOL-BREF) with 26 questions (1998; Skevington et al., 2004) translated to Portuguese (Fleck et al., 2000) was applied at the beginning and at the end of the five-week treatment. This instrument yields four domains (physical health, psychological, social relationships and environment) and two individually scored items regarding overall perception of quality of life (Q1, i.e., first question) and health (Q2, i.e., second question). The four domain scores are scaled in a way that higher scores stand for higher quality of life. These scores were transformed to be comparable with the scores used in the WHOQOL-100 (WHO, 1996).


Other Outcome Measures:
  • Changes on Event-Related Potentials (ERPs) [ Time Frame: Before tDCS treatment (baseline) and after the end of the tDCS treatment (in the third week). ] [ Designated as safety issue: No ]

    Electrophysiological recording will be obtained through a 32-channel system (QuickAmp40, BrainProducts Ltd, Munich, Germany) using active electrodes with an integrated impedance converter for noise subtraction circuits (actiCAP BP; BrainProducts Ltd, Munich, Germany) placed on the scalp according to the International 10/20 EEG system. Data will be recorded with a sampling rate of 1000 Hz, and analog filtered between 0.016 and 1000 Hz with common average reference.

    We adapted a cue-reactivity paradigm (LaRowe et al., 2007) following standard cue-reactivity paradigms well established for pictures (Prisciandaro et al., 2012) and videos (Volkow et al., 2011). During picture presentation the subjects will be asked to press a button whenever the crack-related pictures are presented, and to withhold the response when the neutral pictures are presented (50% of the time).


  • Changes on neuroimaging [ Time Frame: Before tDCS treatment (baseline) and after the end of the tDCS treatment (in the third week). ] [ Designated as safety issue: No ]
    1. FLAIR 3D
    2. T1 3D
    3. Resting State (RS) fMRI
    4. Diffusion Tensor Imaging - DTI


Estimated Enrollment: 54
Study Start Date: November 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: real tDCS
Five 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).
Device: transcranial Direct Current Stimulation
Direct currents will be 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 will be delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode will be placed over F3 according to the 10-20 international system while the anode will be placed over the contralateral F4 region. The currents will flow continuously for 20 minutes with an intensity of 2 milliamperes.
Other Name: tDCS
Sham Comparator: sham-tDCS
Five 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 will be delivered for 20 seconds and will be turned off for the rest of the stimulation period. In this way, subjects will experience the initial itching sensation at the beginning of stimulation, but received no current for the rest of the session.
Device: transcranial Direct Current Stimulation
Direct currents will be 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 will be delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode will be placed over F3 according to the 10-20 international system while the anode will be placed over the contralateral F4 region. The currents will flow continuously for 20 minutes with an intensity of 2 milliamperes.
Other Name: tDCS

Detailed Description:

Before (baseline) and after tDCS or sham-tDCS treatment, subjects will be examined:

  1. clinically, regarding craving (obsessive compulsive scale), depressive (Hamilton depression rating scale) and anxiety (Hamilton anxiety rating scale) symptoms and quality of life of the World Health Organization (WHOQOL-BREF);
  2. cognitively, regarding frontal (Frontal assessment battery), mental state (mini-mental status examination) and working memory (verbal and visual-spatial n-back tasks);
  3. P3 cue-reactivity in visual event-related potentials (ERPs);
  4. neuroimaging: structural (volumetric) and functional such as resting stating functional magnetic resonance (fMRI) and diffusion tensor imaging (DTI).

They will be followed-up for clinical examination at least 6 months after treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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, fourth edition (DSM-IV), 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;
  • any contraindication for magnetic resonance procedures such as electronic implants, metal implants, claustrophobia, or permanent make-up or tattoo received within the previous 3 months;
  • the presence of vascular, traumatic, inflammatory, or tumor injuries detectable by CT examination.
  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: NCT02091167

Contacts
Contact: Ester MN Palacios, MD, PhD 2733376291 emnpalacios@gmail.com

Locations
Brazil
Federal University of Espírito Santo Recruiting
Vitória, ES - Espírito Santo, Brazil, 29060-720
Contact: Ester MN Palacios, MD, PhD    +55 27 33357337    emnpalacios@gmail.com   
Principal Investigator: Ester MN Palacios, MD, PhD         
Sponsors and Collaborators
Federal University of Espirito Santo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Harvard Medical School
University of Göttingen
Investigators
Study Director: Ester MN Palacios, MD, PhD Federal University of Espírito Santo
  More Information

Publications:
Responsible Party: Ester Miyuki Nakamura-Palacios, MD, PhD, Federal University of Espirito Santo
ClinicalTrials.gov Identifier: NCT02091167     History of Changes
Other Study ID Numbers: tDCS CRACK CEP_UFES 384281, CNPq_ 475232/2013-5
Study First Received: March 16, 2014
Last Updated: March 17, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Espirito Santo:
crack-cocaine addiction
tDCS
dlPFC
craving
cognition

Additional relevant MeSH terms:
Substance-Related Disorders
Behavior, Addictive
Cocaine-Related Disorders
Mental Disorders
Compulsive Behavior
Impulsive Behavior
Cocaine
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 24, 2014