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RecruitingNCT07829263Updated Sep 18, 2026

Open-label Feasibility Trial of HD-tDCS During Cognitive Behavioral Therapy for Cocaine Use Disorder

An interventional study of High Definition Transcranial Direct Current Stimulation in Cocaine Use Disorder, sponsored by Virginia Commonwealth University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Cocaine Use Disorder (CocUD) is a significant public health issue with increasing cocaine-related overdose mortality. Effective treatments for CocUD are highly needed. One understudied target for CocUD therapeutics is improving cognitive function (CF) in that key theories attribute development of CocUD and other substance use disorders (SUD) to impaired CF, such as decreased ability to inhibit behavior. Heavy cocaine users show impairments in attention, working memory, planning, and response inhibition, affecting as many as 30-80% of individuals with SUD. These cognitive deficits affect patient engagement and participation in SUD treatment, thus necessitating SUD programs assess and accommodate cognitive problems throughout treatment.

Read the detailed description

Among persons with SUD, those with low CF show more attentional bias toward reward-associated cues, where relapse may stem from reward circuit activation by drug cues that is insufficiently checked by the neurocircuitry of the dorsolateral prefrontal cortex (DLPFC) thought to regulate behavior. Many skills for SUD recovery taught in cognitive behavioral therapy (CBT) are reliant on DLPFC directed top-down regulation, such as recognizing environmental triggers and recalling more healthy coping strategies. However, a challenge for CBT is poor encoding, retention and in situ invocation of these skills. Of interest is improving brain function in these individuals to assist in CBT effectiveness. One option is to use stimulants which have been shown to reduce cocaine use, but they have abuse potential. It is thus critical to discover safer neurobiological interventions that could improve CBT success without risking problematic interactions with commonly prescribed psychotropic medications.

A promising neurobiological intervention for CocUD is transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique that induces changes in neuronal excitability via hypo- or hyper-polarization of underlying resting membrane potentials, resulting in lasting changes in network connectivity that extend beyond the stimulated brain region. When applied over DLPFC, tDCS has been shown to increase memory recall and other CF in older adults with mild cognitive impairment. In SUD, tDCS has also reduced stimulant craving compared to sham stimulation and to reduce rates of relapse in crack cocaine users. In persons with methamphetamine use disorder, tDCS over DLPFC reduced cue-induced drug craving, and this reduction correlated with tDCS-reinforced functional connectivity in the executive control brain network. Thus, tDCS may improve CBT encoding and adherence without potential side effects and abuse potential of medications.

02

Conditions studied

  • Cocaine Use Disorder

Keywords

  • Transcranial Direct Current
  • Cognitive Behavioral Therapy
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Between 18 and 65 years-of-age.
  • Meet current DSM-5 criteria for Cocaine Use Disorder (CocUD), moderate or severe
  • Professed interest in CocUD treatment or reducing cocaine use.
  • Understand and comply with study procedures
  • Positive urine result for cocaine metabolite in at least one screening visit.

Exclusion criteria

Exclusion Criteria

  • Current DSM-5 diagnosis of any non-cocaine substance use disorder (SUD) other than alcohol use disorder-mild or cannabis use disorder-mild
  • Epilepsy or a history of multiple seizures
  • Taking any medications known to reduce seizure threshold
  • History of migraines, ringing in the ears, and/or a head injury that resulted in a diagnosis of concussion and/or loss of consciousness
  • Current scalp condition (e.g. psoriasis) or head wound that has not completely healed
  • Currently pregnant or hoping to become pregnant at any point during the study
  • Significant current suicidal or homicidal ideation
  • Metal plate in skull or other embedded metal fragments in body or other bodily metal
  • Claustrophobia or other MRI contraindications
  • Fitted with electrical implants such as pacemaker
  • Present with clinically significant symptoms of acute cocaine or opioid withdrawal (these individuals would be rescheduled after resolution of acute withdrawal, if possible).
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Left-DLPFC HD-tDCS

    Electrode locations are standardized across participants using the International 10-20 EEG System

    Device: High Definition Transcranial Direct Current Stimulation

  • Experimental
    Right-DLPFC HD-tDCS

    Electrode locations are standardized across participants using the International 10-20 EEG System

    Device: High Definition Transcranial Direct Current Stimulation

Interventions

  • DeviceHigh Definition Transcranial Direct Current Stimulation

    Stim-CBT program consists of eight, 60-minute individual therapy sessions with a VCU clinical psychology doctoral student who will present CBT program modules remotely by Zoom.

    Also known as: Stim-CBT

05

What researchers measure

Primary outcomes

  1. Cocaine use

    Subjects will be monitored for cocaine-positive urine sample, proportion of the visit samples that are negative for cocaine metabolites.

    Time frame: Baseline Task Visit, Baseline MRI Visit, during 8 HD-tDCS CBT visits, Follow-up MRI visit, Debrief visit (1 week after Follow-up MRI visit)

Secondary outcomes

  1. Medication Compliance

    Utilizing the mobile phone app

    Time frame: Baseline Task Visit, Baseline MRI Visit, during 8 HD-tDCS CBT visits, Follow-up MRI visit, Debrief visit (1 week after Follow-up MRI visit)

06

Study locations

1 of 1 sites recruiting
  • Virginia Commonwealth University
    Richmond, Virginia 23298, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07829263
Lead sponsor
Virginia Commonwealth University
Responsible party
Sponsor
First posted
Sep 18, 2026
Start date
Sep 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 18, 2026

Study contacts

Brooke Moorman
Contact
moormanba@vcu.edu
804-828-6494
Lisa Straub
Contact
lisa.kstraub@vcuhealth.org
(804) 828-6494
James Bjork
principal investigator · Virginia Commonwealth University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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