Recruiting

Cognitive Function

Sponsor:

Virginia Commonwealth University

Code:

NCT07829263

Conditions

Cocaine Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

High Definition Transcranial Direct Current Stimulation

Study Details

Brief 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.

Conditions

Cocaine Use Disorder

Study ID

NCT07829263

Start date

Sep, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

  • 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).

Study Design

Enrollment

36 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Left-DLPFC HD-tDCS

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

experimental: Right-DLPFC HD-tDCS

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

Interventions

High 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.

Primary outcome measure

  • Cocaine use [ 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) ]

Central Contacts and Locations

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Principal Investigator:

James Bjork

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Sep 18, 2026

Last verified

Sep, 2026

Keywords

  • Transcranial Direct Current
  • Cognitive Behavioral Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-09-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.