TDCS to Reduce Craving in Cocaine Addiction- Phase 2 Study

NCT04994821 | Completed Phase 2 DMC FDA Device

• 2 other identifiers: SMIMS09282020HS# 18-01324, GCO# 18-1920
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Use Disorder; Cocaine Dependence

Keywords

Transcranial Direct Current Stimulation; tDCS; Brain Stimulation; Cocaine Addiction; Drug Craving

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)

Secondary Outcomes (5)

• Change in Depression symptoms from Baseline (Ham-D score)

  Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)

• Change in Anxiety symptoms from Baseline (HAM-A score)

  Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)

• Change in Quality of Life from Baseline (WHOQOL-BREF score)

  Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)

• EEG Late Positive Potential from Baseline

  Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)

• Urine Test Analysis from Baseline

  Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)

Study Arms (3)

Active tDCS

EXPERIMENTAL

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

Device: transcranial direct current stimulator (tDCS)

Sham tDCS

SHAM COMPARATOR

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

Device: transcranial direct current stimulator (tDCS)

Active tDCS with Cognitive Reappraisal (CR)

EXPERIMENTAL

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

Device: transcranial direct current stimulator (tDCS); Behavioral: Cognitive Reappraisal

Interventions

transcranial direct current stimulator (tDCS) DEVICE

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

Also known as: Soterix Medical mini-CT tDCS stimulator

Active tDCS; Active tDCS with Cognitive Reappraisal (CR); Sham tDCS

Cognitive Reappraisal BEHAVIORAL

Emotion regulation therapy

Active tDCS with Cognitive Reappraisal (CR)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Soterix Medical: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (7)

• 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.

  PMID: 26065432 BACKGROUND

• 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.

  PMID: 30193898 BACKGROUND

• 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.

  PMID: 28937310 BACKGROUND

• 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.

  PMID: 28225155 BACKGROUND

• 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.

  PMID: 29735157 BACKGROUND

• 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.

  PMID: 27434467 BACKGROUND

• 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.

  PMID: 27603142 BACKGROUND

Related Links

• Soterix Medical

MeSH Terms

Conditions

Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Abhishek Datta, PhD

  Soterix Medical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple Masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 6, 2021
• Study Start: September 28, 2020
• Primary Completion: March 31, 2022
• Study Completion: September 30, 2022
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)