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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVirginia Commonwealth University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Left-DLPFC HD-tDCSExperimental treatment 1 intervention
Group B: Right-DLPFC HD-tDCSExperimental treatment 1 intervention

Trial outcomes

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)

Other outcomes

Sponsors and contacts

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