NCT07318480

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

Cognitively-enhanced tDCS of the Dorsolateral Prefrontal Cortex to Reduce Craving in Cocaine Addiction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DEVICE	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
BEHAVIORAL	Cognitive Reappraisal Training	Cognitive reappraisal of drug cues during stimulation sessions

Timeline

• Start date: 2026-02-25
• Primary completion: 2030-02-01
• Completion: 2030-02-01
• First posted: 2026-01-06
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study