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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03842137
Other study ID # 1810-001
Secondary ID UG3DA047793
Status Completed
Phase N/A
First received
Last updated
Start date June 4, 2019
Est. completion date August 31, 2023

Study information

Verified date May 2024
Source Butler Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 functional magnetic resonance imaging (FMRI) and electroencephalographic (EEG), once prior to tDCS+CCN priming and again at the completion of 5 sessions of tDCS+CCN priming (one week later). Task-based and resting state functional connectivity will be used to examine networks associated with craving (CR) and cognitive control. In Phase 1, FMRI and EEG will provide validation of expected changes in these networks following tDCS stimulation of the DLPFC.


Description:

This study has two phases. In phase one (UG3), the investigators propose to use FMRI to quantify changes in brain function and 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 using FMRI and EEG, once prior to tDCS and again one week later after completion of 5 sessions of tDCS+CCN priming. With a focus on the craving outcome, the investigators will use two task-based FMRI paradigms that challenge networks associated with craving (CR) and cognitive control (CCN), and will examine these and the salience network using resting state functional connectivity. In Phase 1, FMRI and 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 greater FMRI change in any node of the CR or CCN networks or enhanced frontal theta power during a WM task AND greater change (at least 10% difference between conditions, controlling for baseline craving) in subjective craving measured during a cue reactivity task or outside the FMRI following the tDCS+CCN priming intervention compared to sham tDCS+CCN priming.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date August 31, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers No
Gender All
Age group 21 Years to 50 Years
Eligibility 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 Exclusion Criteria related to FMRI scanning are: - history of neurological disorder (e.g., epilepsy, stroke, brain injury with loss of consciousness>10 min) - impaired uncorrected vision - MRI contraindications (e.g., claustrophobia, specific metallic implants and injuries, and pregnancy)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
tDCS
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.
sham tDCS
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.

Locations

Country Name City State
United States Butler Hospital Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
Butler Hospital National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary changes in opioid craving Penn Alcohol Craving (Modified for Opioids) (scoring: 0 - 30, higher scores = more craving) 2 week
Primary change in EEG oscillatory targets frontal theta activity during working memory 2 week
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