Clinical trial NCT03842137: tDCS to Decrease Opioid Relapse (UG3)
Official title: tDCS to Decrease Opioid Relapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Dependence
Craving
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-02-15
Enrollment: 62
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Opioid Craving
timeFrame: 2 week
Secondary outcomes:
measure: EEG Theta Brainwave Activity
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Ana M Abrantes, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Michael D Stein, M.D.
role: PRINCIPAL_INVESTIGATOR
References: