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tDCS to Reduce Craving in Cocaine Addiction

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ClinicalTrials.gov Identifier: NCT03833583
Recruitment Status : Recruiting
First Posted : February 7, 2019
Last Update Posted : February 7, 2019
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Soterix Medical

Brief Summary:

Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation in which low level electrical currents are applied to the scalp in order to alter brain function. In the present study, tDCS will be administered with the goal of assessing the tolerability and feasibility of this approach to 1) reduce an individual's level of drug craving and 2) provide evidence to support the use of this device by the patient for future unsupervised stimulation in a non-clinical setting.

Research Questions:

  • Can tDCS be used successfully to train cocaine addicted individuals for self-administration purposes?
  • Can active tDCS be used to decrease drug craving in individuals with cocaine use disorders?
  • Does active tDCS outperform sham tDCS in reducing drug craving?

Condition or disease Intervention/treatment Phase
Cocaine Use Disorder Cocaine Dependence Device: Soterix Medical mini-CT tDCS stimulator Not Applicable

Detailed Description:

The ultimate goal of this project is to develop a portable neuromodulatory intervention to reduce craving in cocaine addiction. This proposed project is in response to NIH/NIDA's solicitation titled "Development of Portable Neuromodulatory Device for the Treatment of Substance Use Disorders (SUDs)." The present study aims to evaluate the tolerability and feasibility of repeated administration of tDCS to reduce drug craving in individuals with cocaine addiction, with the aim of using these data to support a phase II study and, ultimately, support of approval of usage of this device without clinical supervision.

The specific objectives are:

  1. Establish the feasibility and safety of using tDCS to reduce self-reported cravings in individuals addicted to cocaine.
  2. Train cocaine addicted individuals to self-administer tDCS (under supervision) to test the feasibility of future home self-administration in this population.

Substance use disorders present a treatment challenge for clinicians, as well as a socioeconomic burden on individuals and society at large. Cocaine use disorder occurs when someone experiences clinically significant impairment caused by the recurrent use of cocaine, including health problems, physical withdrawal with discontinuation of use, persistent/escalating use, and failure to meet major personal, occupational, or educational responsibilities. At present, no FDA approved medicines are available to treat cocaine dependence, and behavioral therapy may be used to treat this addiction, though with limited efficacy. Drug craving (strong obsessions about and/or irresistible urges or compulsions to consume a drug) is a central driving force for perpetuation of substance use and subsequent addiction, as well as relapse after abstinence. Currently, no treatments exist that are targeted at reducing drug craving, which is intrusive and distressing to patients. The prefrontal cortex (PFC) plays an important role inhibiting these intrusive cravings. However, decades of data have shown that PFC activity is impaired in addictions. In this study, our goal is to increase PFC activity with non-invasive neuromodulation. Given the role of the PFC in the processing and regulation of craving behavior, this brain region is a key target for brain stimulation.

This study will recruit individuals with a diagnosis of cocaine use disorder (per DSM-5 criteria) who are receiving treatment for their substance use disorder at Samaritan Daytop Village (SDV) and other similar treatment facilities (e.g., Phoenix House, Mount Sinai's network of hospitals and clinics). Patients will be randomly assigned to receive either active or sham (placebo) tDCS. Participants will receive 20 minutes of stimulation per tDCS day, three days per week for five weeks.

Interviews and neuropsychological testing will be conducted, and self-reported drug craving and addiction severity questionnaires will be used. Follow up cognitive and behavioral assessments will be conducted over a period of 12 months post tDCS stimulation. In addition, participants will be asked to perform EEG, cognitive tasks, and collection of a blood sample to assess genetic/epigenetic patterns.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Device Feasibility
Official Title: Transcranial Direct Current Stimulation (tDCS) to Reduce Craving in Cocaine Addiction
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active tDCS
Active Transcranial Direct Current Stimulation (tDCS), Soterix Medical mini-CT tDCS stimulator
Device: Soterix Medical mini-CT tDCS stimulator

Patients will have two electrodes applied (one anode, one cathode) administering active (real) or sham (placebo, not real) tDCS stimulation.

Stimulation will last 20 minutes per day, three days per week, for 5 weeks


Sham Comparator: Sham tDCS
Sham (Placebo) Transcranial Direct Current Stimulation (tDCS), Soterix Medical mini-CT tDCS stimulator
Device: Soterix Medical mini-CT tDCS stimulator

Patients will have two electrodes applied (one anode, one cathode) administering active (real) or sham (placebo, not real) tDCS stimulation.

Stimulation will last 20 minutes per day, three days per week, for 5 weeks





Primary Outcome Measures :
  1. Change in Cocaine Craving from Baseline (Obsessive-Compulsive Cocaine Scale score) [ Time Frame: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (every three months for up to 1 year) ]
    Craving for cocaine will be assessed with a brief scale composed of 5 items (1, 2, 4, 5, and 13) from the Obsessive-Compulsive Cocaine Scale (OCCS; Vorspan et al., 2012).


Secondary Outcome Measures :
  1. Change in Depression symptoms from Baseline (Ham-D score) [ Time Frame: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (every three months for up to 1 year) ]
    Depression symptoms will be assessed by the Hamilton Rating Scale for Depression (24 item version, HAM-D; Hamilton, 1960).

  2. Change in Anxiety symptoms from Baseline (HAM-A score) [ Time Frame: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (every three months for up to 1 year) ]
    Anxiety symptoms will be assessed by the Hamilton Rating Scale for Anxiety (HAM-A; Hamilton, 1959).

  3. Change in Quality of Life from Baseline (WHOQOL-BREF score) [ Time Frame: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (every three months for up to 1 year) ]
    An abbreviated instrument of cross-culturally valid assessment of quality of life of the World Health Organization (WHOQOL-BREF) with 26 questions (WHOQOL Group, 1998; Skevington et al., 2004) yields 4 domains (physical health, psychological, social relationships, and environment) and 2 individually scored items regarding overall perception of quality of life (Q1) and health (Q2). The 4 domain scores are scaled in a way that higher scores stand for higher quality of life.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-5 diagnosis of cocaine use disorder
  • Ability to understand the risks/benefits of the study, provide informed consent and perform tasks as per protocol
  • English speaking
  • For females of childbearing capacity, current use of a medically acceptable form of birth control

Exclusion Criteria:

  • Current or past history of a major neurological disorder (e.g. mental retardation, Parkinson's disease, Lewy body disease, Huntington's disease, MS, ALS, stroke, delirium tremens) or seizures, including those symptoms associated with periods of cocaine withdrawal or abstinence
  • History of Axis I disorder, other than substance use disorder, that is associated with psychotic symptoms (e.g. schizophrenia) or neurodevelopmental disorder (e.g., autism)
  • Use of medications (current or in the past 6 months) with known CNS effects or which may alter cerebral function, except psychotropics for depression/anxiety/PTSD (e.g. SSRIs)
  • Clinically significant unstable medical illness or infection (e.g. HIV, hepatitis, etc.)
  • Presence of contraindicated metallic implants or devices which may be impacted by electrical stimulation (e.g. cardiac pacemaker/defibrillator, medication pump, cochlear implant, implanted brain stimulator)
  • Head trauma with loss of consciousness for more than 30 minutes
  • Pregnancy or breast feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833583


Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: NARC Program    855-795-4837    narc@mssm.edu   
Contact: Jaimie Gowatsky, MA       jaimie.gowatsky@mssm.edu   
Principal Investigator: Rita Z Goldstein, PhD         
Sub-Investigator: Nelly Alia-Klein, PhD         
Sub-Investigator: Muhammad A Parvaz, PhD         
Sponsors and Collaborators
Soterix Medical
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Abhishek Datta, PhD Soterix Medical

Additional Information:
Publications:

Responsible Party: Soterix Medical
ClinicalTrials.gov Identifier: NCT03833583     History of Changes
Other Study ID Numbers: SMIN2712-P1
HS# 18-01324, GCO# 18-1920 ( Other Identifier: Icahn School of Medicine at Mount Sinai )
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Soterix Medical:
Transcranial Direct Current Stimulation
tDCS
Brain Stimulation
Cocaine Addiction
Drug Craving

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