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

NCT07829263 | Recruiting

• 1 other identifier: HM300000418
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Transcranial Direct Current; Cognitive Behavioral Therapy

Outcome Measures

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.

  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

  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)

Study Arms (2)

Left-DLPFC HD-tDCS

EXPERIMENTAL

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

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

Device: High Definition Transcranial Direct Current Stimulation

Interventions

High Definition Transcranial Direct Current Stimulation DEVICE

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

Left-DLPFC HD-tDCS; Right-DLPFC HD-tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

Study Officials

• James Bjork

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brooke Moorman

CONTACT

804-828-6494; dneurolab@vcu.edu

Lisa Straub

CONTACT

(804) 828-6494; dneurolab@vcu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomization will occur once eligibility has been confirmed during visit. The first participant will be randomized by flipping a coin. Subsequent participants will be randomized by alternating based on the last participant randomized.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Female and Male Adults with CocUD, Quasi-Experimental Design

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)