Transcranial Direct Current Stimulation (tDCS) for Treatment of Cocaine Use Disorder

NCT ID: NCT07318480

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2030-02-28

Brief Summary

The researchers will test whether cognitively enhanced transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex can reduce craving in inpatients with cocaine use disorder. Neuroimaging before and after stimulation will establish the neural correlates of recovery and allow predictions of outcomes, which will be assessed throughout the study and one month after its completion. Results could pave the way towards development of a new self-administered intervention to reduce craving when it is needed the most, enhancing recovery real-time and in the natural environment in people with cocaine addiction as generalizable to other drugs of abuse and other disorders of self-control.

Detailed Description

Over the past decade, the US has been affected by a re-emerging stimulant use public health crisis and alarming increases in crack/cocaine-related overdose deaths. In contrast to other types of addiction, there are no FDA approved treatments for crack/cocaine use disorder (CUD). Developing and testing evidence-based treatment options for this population, and exploring the underlying neural substrates, are therefore urgently needed. Core symptoms of addiction are craving and heightened reactivity to drug cues, attributed to impairments in prefrontal functions. This study builds upon Phase-1 and Phase-2 trials testing whether transcranial direct current stimulation (tDCS) targeting the dorsolateral prefrontal cortex can reduce craving in treatment-seeking inpatients with CUD. Participants will be randomized to receive real or sham tDCS, combined with cognitive reappraisal training of drug cues or a control condition, in a double-blind, factorial design (N=120). Craving and drug use outcomes will be assessed throughout the intervention and at one-month follow-up. Neuroimaging will be used to examine neural correlates of treatment response. Results may inform development of scalable, self-administered interventions to reduce craving and relapse risk in cocaine addiction.

Conditions

Cocaine Use Disorder; Cocaine Dependence; Substance Use Disorder (SUD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active tDCS with Cognitive Reappraisal (CR)

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

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulator (tDCS)

Intervention Type: DEVICE

Participants will have two electrodes applied (one anode, one cathode) administering active (real) or sham (placebo, not real) tDCS stimulation of the dorsolateral prefrontal cortex.

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

Cognitive Reappraisal Training

Intervention Type: BEHAVIORAL

Cognitive reappraisal of drug cues during stimulation sessions

Active tDCS

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

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulator (tDCS)

Intervention Type: DEVICE

Participants will have two electrodes applied (one anode, one cathode) administering active (real) or sham (placebo, not real) tDCS stimulation of the dorsolateral prefrontal cortex.

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

Sham tDCS

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

Group Type: SHAM_COMPARATOR

Transcranial Direct Current Stimulator (tDCS)

Intervention Type: DEVICE

Participants will have two electrodes applied (one anode, one cathode) administering active (real) or sham (placebo, not real) tDCS stimulation of the dorsolateral prefrontal cortex.

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

Sham tDCS with Cognitive Reappraisal (CR)

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

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulator (tDCS)

Intervention Type: DEVICE

Participants will have two electrodes applied (one anode, one cathode) administering active (real) or sham (placebo, not real) tDCS stimulation of the dorsolateral prefrontal cortex.

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

Cognitive Reappraisal Training

Intervention Type: BEHAVIORAL

Cognitive reappraisal of drug cues during stimulation sessions

Interventions

Transcranial Direct Current Stimulator (tDCS)

Participants will have two electrodes applied (one anode, one cathode) administering active (real) or sham (placebo, not real) tDCS stimulation of the dorsolateral prefrontal cortex.

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

Intervention Type: DEVICE

Cognitive Reappraisal Training

Cognitive reappraisal of drug cues during stimulation sessions

Intervention Type: BEHAVIORAL

Other Intervention Names

Soterix Medical mini-CT tDCS stimulator

Eligibility Criteria

Inclusion Criteria

• Ability to understand and give informed consent
• Men and women 18-60 years of age.
• For women of childbearing potential, current use of a medically acceptable form of birth control
• DSM-5 diagnosis of stimulant use disorder with crack/cocaine as the drug of choice

Exclusion Criteria

• Lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, or delusional disorder as confirmed by the MINI or autism spectrum disorder as confirmed by medical history at the screening visit
• Current clinically significant or unstable medical conditions, including metabolic, endocrinological, oncological or autoimmune diseases, infectious diseases common in people with substance use disorders including Hepatitis B and C or HIV/AIDS; use of medications deemed exclusionary by the study team; or any laboratory value outside the reference range that the senior investigator team considers to be of clinical relevance
• Head trauma with loss of consciousness (>30 min)
• History of neurological or developmental disease of central origin including stroke, brain tumor or seizures, encompassing those symptoms associated with periods of drug withdrawal or abstinence
• Metal implants or devices that may be impacted by the electrical stimulation and additional MR contraindications
• Women of childbearing potential must use a medically acceptable birth control method during the study and will be asked to take a pregnancy urine test before exposure to tDCS (or MRI)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Soterix Medical

INDUSTRY

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Rita Goldstein

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rita Goldstein, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kathryn Rachel Drury Clinical Research Coordinator

Role: CONTACT

NARC@mssm.edu

646-937-2875

Maggie Boros Clinical Research Coordinator

Role: CONTACT

NARC@mssm.edu

646-937-2875

Facility Contacts

Rachel Drury

Role: primary

NARC@mssm.edu

646-937-2875

Other Identifiers

R01DA060914

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 23-1756

Identifier Type: -

Identifier Source: org_study_id