Open-label Feasibility Trial of HD-tDCS During Cognitive Behavioral Therapy for Cocaine Use Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Brooke Moorman
- Phone Number: 804-828-6494
- Email: moormanba@vcu.edu
Study Contact Backup
- Name: Lisa Straub
- Phone Number: (804) 828-6494
- Email: lisa.kstraub@vcuhealth.org
Study Locations
-
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Virginia
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Richmond, Virginia, United States, 23298
- Recruiting
- Virginia Commonwealth University
-
Contact:
- Lisa Straub
- Phone Number: 804-828-6494
- Email: lisa.kstraub@vcuhealth.org
-
Contact:
- Brooke Moorman
- Email: moormanba@vcu.edu
-
Principal Investigator:
- James Bjork
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Left-DLPFC HD-tDCS
Electrode locations are standardized across participants using the International 10-20 EEG System
|
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.
Other Names:
|
|
Experimental: Right-DLPFC HD-tDCS
Electrode locations are standardized across participants using the International 10-20 EEG System
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medication Compliance
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)
|
Utilizing the mobile phone app
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James Bjork, Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HM300000418
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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