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tDCS to Reduce Craving in Cocaine Addiction- Phase 2 Study

Primary Purpose

Cocaine Use Disorder, Cocaine Dependence

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
transcranial direct current stimulator (tDCS)
Cognitive Reappraisal
Sponsored by
Soterix Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Use Disorder focused on measuring Transcranial Direct Current Stimulation, tDCS, Brain Stimulation, Cocaine Addiction, Drug Craving

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Icahn School of Medicine at Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Experimental

Arm Label

Active tDCS

Sham tDCS

Active tDCS with Cognitive Reappraisal (CR)

Arm Description

Active Transcranial Direct Current Stimulation (tDCS), (Soterix Medical mini-CT tDCS stimulator)

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

Active Transcranial Direct Current Stimulation (tDCS) (Soterix Medical mini-CT tDCS stimulator), and Cognitive Reappraisal (CR)

Outcomes

Primary Outcome Measures

Change in Cocaine Craving from Baseline (Obsessive-Compulsive Cocaine Scale score)
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

Change in Depression symptoms from Baseline (Ham-D score)
Depression symptoms will be assessed by the Hamilton Rating Scale for Depression (24 item version, HAM-D; Hamilton, 1960).
Change in Anxiety symptoms from Baseline (HAM-A score)
Anxiety symptoms will be assessed by the Hamilton Rating Scale for Anxiety (HAM-A; Hamilton, 1959).
Change in Quality of Life from Baseline (WHOQOL-BREF score)
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.
EEG Late Positive Potential from Baseline
The Late Positive Potential (LLP), also known as the Late Positive Wave, is an Event Related Potential (ERP) that is formed approximately 400 ms after exposure to a stimulus and continues until about 2 s after the exposure. Higher LPP amplitude has been shown to indicate a higher level of cocaine craving (Parvaz 2016). We will present images of cocaine-related tasks to subjects and measure the amplitude of the LPP using a 64-electrode EEG cap. We will compare the LPP amplitude at each testing session to baseline amplitude.
Urine Test Analysis from Baseline
Testing for the presence of cocaine in urine samples

Full Information

First Posted
July 28, 2021
Last Updated
August 13, 2021
Sponsor
Soterix Medical
Collaborators
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT04994821
Brief Title
tDCS to Reduce Craving in Cocaine Addiction- Phase 2 Study
Official Title
A Phase 2 Study to Investigate Use of Transcranial Direct Current Stimulation (tDCS) to Reduce Craving in Cocaine Addiction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 28, 2020 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soterix Medical
Collaborators
Icahn School of Medicine at Mount Sinai

4. Oversight

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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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 a prior Phase-I study, the research team demonstrated feasibility of self-administration of a home-tDCS prototype in 14 patients that applied 15 sessions for each patient at an outpatient center.
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 increase the efficacy of repeated administration of tDCS to reduce drug craving in individuals with cocaine addiction. 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 into three groups: active (real-tDCS), real-tDCS and Cognitive Reappraisal (CR), 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Use Disorder, Cocaine Dependence
Keywords
Transcranial Direct Current Stimulation, tDCS, Brain Stimulation, Cocaine Addiction, Drug Craving

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Quadruple Masking
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Experimental
Arm Description
Active Transcranial Direct Current Stimulation (tDCS), (Soterix Medical mini-CT tDCS stimulator)
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Sham (Placebo) Transcranial Direct Current Stimulation (tDCS), Soterix Medical mini-CT tDCS stimulator
Arm Title
Active tDCS with Cognitive Reappraisal (CR)
Arm Type
Experimental
Arm Description
Active Transcranial Direct Current Stimulation (tDCS) (Soterix Medical mini-CT tDCS stimulator), and Cognitive Reappraisal (CR)
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulator (tDCS)
Other Intervention Name(s)
Soterix Medical mini-CT tDCS stimulator
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Reappraisal
Intervention Description
Emotion regulation therapy
Primary Outcome Measure Information:
Title
Change in Cocaine Craving from Baseline (Obsessive-Compulsive Cocaine Scale score)
Description
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).
Time Frame
Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)
Secondary Outcome Measure Information:
Title
Change in Depression symptoms from Baseline (Ham-D score)
Description
Depression symptoms will be assessed by the Hamilton Rating Scale for Depression (24 item version, HAM-D; Hamilton, 1960).
Time Frame
Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)
Title
Change in Anxiety symptoms from Baseline (HAM-A score)
Description
Anxiety symptoms will be assessed by the Hamilton Rating Scale for Anxiety (HAM-A; Hamilton, 1959).
Time Frame
Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)
Title
Change in Quality of Life from Baseline (WHOQOL-BREF score)
Description
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.
Time Frame
Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)
Title
EEG Late Positive Potential from Baseline
Description
The Late Positive Potential (LLP), also known as the Late Positive Wave, is an Event Related Potential (ERP) that is formed approximately 400 ms after exposure to a stimulus and continues until about 2 s after the exposure. Higher LPP amplitude has been shown to indicate a higher level of cocaine craving (Parvaz 2016). We will present images of cocaine-related tasks to subjects and measure the amplitude of the LPP using a 64-electrode EEG cap. We will compare the LPP amplitude at each testing session to baseline amplitude.
Time Frame
Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)
Title
Urine Test Analysis from Baseline
Description
Testing for the presence of cocaine in urine samples
Time Frame
Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abhishek Datta, PhD
Organizational Affiliation
Soterix Medical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NARC Program
Phone
855-795-4837
Email
narc@mssm.edu
First Name & Middle Initial & Last Name & Degree
Pierre-Olivier Gaudreault, PhD
Email
pierre-olivier.gaudreault@mssm.edu
First Name & Middle Initial & Last Name & Degree
Rita Z Goldstein, PhD
First Name & Middle Initial & Last Name & Degree
Nelly Alia-Klein, PhD
First Name & Middle Initial & Last Name & Degree
Muhammad A Parvaz, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
30193898
Citation
Agarwal S, Pawlak N, Cucca A, Sharma K, Dobbs B, Shaw M, Charvet L, Biagioni M. Remotely-supervised transcranial direct current stimulation paired with cognitive training in Parkinson's disease: An open-label study. J Clin Neurosci. 2018 Nov;57:51-57. doi: 10.1016/j.jocn.2018.08.037. Epub 2018 Sep 5.
Results Reference
background
PubMed Identifier
28937310
Citation
Charvet LE, Dobbs B, Shaw MT, Bikson M, Datta A, Krupp LB. Remotely supervised transcranial direct current stimulation for the treatment of fatigue in multiple sclerosis: Results from a randomized, sham-controlled trial. Mult Scler. 2018 Nov;24(13):1760-1769. doi: 10.1177/1352458517732842. Epub 2017 Sep 22.
Results Reference
background
PubMed Identifier
28225155
Citation
Charvet L, Shaw M, Dobbs B, Frontario A, Sherman K, Bikson M, Datta A, Krupp L, Zeinapour E, Kasschau M. Remotely Supervised Transcranial Direct Current Stimulation Increases the Benefit of At-Home Cognitive Training in Multiple Sclerosis. Neuromodulation. 2018 Jun;21(4):383-389. doi: 10.1111/ner.12583. Epub 2017 Feb 22.
Results Reference
background
PubMed Identifier
29735157
Citation
Moeller SJ, Zilverstand A, Konova AB, Kundu P, Parvaz MA, Preston-Campbell R, Bachi K, Alia-Klein N, Goldstein RZ. Neural Correlates of Drug-Biased Choice in Currently Using and Abstinent Individuals With Cocaine Use Disorder. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 May;3(5):485-494. doi: 10.1016/j.bpsc.2017.11.001. Epub 2017 Nov 11.
Results Reference
background
PubMed Identifier
27434467
Citation
Parvaz MA, Moeller SJ, Malaker P, Sinha R, Alia-Klein N, Goldstein RZ. Abstinence reverses EEG-indexed attention bias between drug-related and pleasant stimuli in cocaine-addicted individuals. J Psychiatry Neurosci. 2016 Jul 19;41(5):150358. doi: 10.1503/jpn.150358. Online ahead of print.
Results Reference
background
PubMed Identifier
27603142
Citation
Parvaz MA, Moeller SJ, Goldstein RZ. Incubation of Cue-Induced Craving in Adults Addicted to Cocaine Measured by Electroencephalography. JAMA Psychiatry. 2016 Nov 1;73(11):1127-1134. doi: 10.1001/jamapsychiatry.2016.2181.
Results Reference
background
Links:
URL
https://soterixmedical.com/
Description
Soterix Medical
URL
https://icahn.mssm.edu/research/narc
Description
Neuropsychoimaging of Addiction and Related Conditions (NARC) Research Program, Icahn School of Medicine at Mount Sinai

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tDCS to Reduce Craving in Cocaine Addiction- Phase 2 Study

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