Clinical trial NCT04994821: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine Use Disorder
Cocaine Dependence
Keywords: Transcranial Direct Current Stimulation
tDCS
Brain Stimulation
Cocaine Addiction
Drug Craving
Lead sponsor: Soterix Medical
Sponsor class: INDUSTRY
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2021-08-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change in Cocaine Craving from Baseline (Obsessive-Compulsive Cocaine Scale score)
timeFrame: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)
Secondary outcomes:
measure: Change in Depression symptoms from Baseline (Ham-D score)
timeFrame: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)
measure: Change in Anxiety symptoms from Baseline (HAM-A score)
timeFrame: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)
measure: Change in Quality of Life from Baseline (WHOQOL-BREF score)
timeFrame: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)
measure: EEG Late Positive Potential from Baseline
timeFrame: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)
measure: Urine Test Analysis from Baseline
timeFrame: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Soterix Medical
name: Abhishek Datta, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.