tDCS to Reduce Craving in Cocaine Addiction

Sponsor

Soterix Medical (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03833583

Collaborator

Icahn School of Medicine at Mount Sinai (Other)

Enrollment

Location

Arms

7.9

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

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 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	N/A

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:

Establish the feasibility and safety of using tDCS to reduce self-reported cravings in individuals addicted to cocaine.
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 Design

Study Type:

Interventional

Anticipated 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 :

Feb 1, 2019

Anticipated Primary Completion Date :

Sep 30, 2019

Anticipated Study Completion Date :

Sep 30, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Change in Depression symptoms from Baseline (Ham-D score) [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).
Change in Anxiety symptoms from Baseline (HAM-A score) [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).
Change in Quality of Life from Baseline (WHOQOL-BREF score) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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