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.
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
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- 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.
United States1 site, 1 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Lisa Straub, 804-828-6494, dneurolab@vcu.edu
Brooke Moorman, dneurolab@vcu.edu
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.
- Conditions
- Cocaine Use Disorder
- 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 group | Role | What they receive |
|---|---|---|
| Left-DLPFC HD-tDCS | Experimental | Electrode locations are standardized across participants using the International 10-20 EEG System Receives: Device: High Definition Transcranial Direct Current Stimulation |
| Right-DLPFC HD-tDCS | Experimental | Electrode 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.
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)
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.
- First posted18 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Bjork, Principal investigator, Virginia Commonwealth University
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