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Cocaine Use DisorderNCT07829263

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

A study testing High Definition Transcranial Direct Current Stimulation in people with Cocaine Use Disorder, run by Virginia Commonwealth University at 1 site in United States.

Recruiting

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Sites and contacts
Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Cocaine Use Disorder
What is being tested?
High Definition Transcranial Direct Current Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
Oct 2026to Dec 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brooke Moorman contact

804-828-6494

dneurolab@vcu.edu

United States1 site, 1 recruiting
  • Virginia Commonwealth University

    Richmond, Virginia, 23298

    Lisa Straub, 804-828-6494, dneurolab@vcu.edu

    Brooke Moorman, dneurolab@vcu.edu

    Recruiting

Other trials in United States

About this study

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.

Being tested
High Definition Transcranial Direct Current Stimulation
Keywords
Transcranial Direct Current, Cognitive Behavioral Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Definition Transcranial Direct Current StimulationDevice

    Also called Stim-CBT

    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.

Study groups in NCT07829263
Study groupRoleWhat they receive
Left-DLPFC HD-tDCSExperimentalElectrode locations are standardized across participants using the International 10-20 EEG System
Receives: Device: High Definition Transcranial Direct Current Stimulation
Right-DLPFC HD-tDCSExperimentalElectrode locations are standardized across participants using the International 10-20 EEG System
Receives: Device: High Definition Transcranial Direct Current Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cocaine use

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

    Measured: 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)
  1. Medication Compliance

    Utilizing the mobile phone app

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Model description
Female and Male Adults with CocUD, Quasi-Experimental Design
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07829263
Sponsor's protocol ID
HM300000418
Status last verified
Sep 2026
First submitted
14 Sep 2026
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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