tDCS to Decrease Opioid Relapse (UG3)

Butler Hospital

Status: Completed

Conditions: Craving; Opioid Dependence

Treatments: Device: sham tDCS; Device: tDCS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03842137

1810-001

UG3DA047793 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

In the current proposal, the investigators will measure behavioral and brain responses following transcranial direct current stimulation (tDCS) to the dorsolateral prefrontal cortex (DLPFC) (anode on right DLPFC, cathode on the left DLPFC) delivered during cognitive control network (CCN) priming. Participants with opioid dependence, in the first month of prescribed buprenorphine or methadone, will be assessed twice using electroencephalographic (EEG), once prior to tDCS+CCN priming and again at the completion of 5 sessions of tDCS+CCN priming (one week later). EEG will provide validation of expected changes in these networks following tDCS stimulation of the DLPFC.

Full description

Investigators propose to use EEG to examine oscillatory brain changes as well as self-reported craving before and after administration of five sessions of tDCS+Cognitive Control Network (CCN) priming stimulation vs. sham tDCS+CCN priming (randomized control trial) in 60 opioid dependent participants who recently initiated buprenorphine or methadone. Participants in the first month of prescribed buprenorphine or methadone will be assessed EEG, once prior to tDCS and again one week later after completion of 5 sessions of tDCS+CCN priming. EEG will be expected to provide 1) validation of expected network and oscillatory changes from tDCS-targeting and 2) an effect size for DLPFC vs sham stimulation. Go/no go criteria for the UG3 phase will be demonstration of enhanced frontal theta power during a WM task AND greater change (at least 10% difference between conditions, controlling for baseline craving) in subjective craving following the tDCS+CCN priming intervention compared to sham tDCS+CCN priming.

Enrollment: 62 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• current opioid dependence
• between 21-50 years of age
• recent initiation of buprenorphine or methadone (<30 days)

Exclusion criteria

• current criteria for a DSM-V diagnosis of bipolar disorder, schizophrenia, schizo-affective, schizophreniform, or paranoid disorder
• current suicidality
• evidence of neurocognitive dysfunction
• contraindications for tDCS (e.g seizure disorder)
• probation/parole requirements or an upcoming move that might interfere with protocol participation
• planning to terminate buprenorphine in less than 3 months
• scalp lesions near the tDCS electrode sites

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 2 patient groups

tDCS

Active Comparator group

Description:

Each participant will undergo 5 consecutive (i.e., business days) sessions of active tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.

Treatment:

Device: tDCS

sham tDCS

Sham Comparator group

Description:

Each participant will undergo 5 consecutive (i.e., business days) sessions of sham tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.

Treatment:

Device: sham tDCS