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Completed

NCT Number: NCT03842137

tDCS to Decrease Opioid Relapse (UG3)

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.

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Key information

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tDCS

Device

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

Device

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.

Primary outcomes

  1. Opioid Craving

    Time frame: 2 week

    Penn Alcohol Craving (Modified for Opioids). This is a 5-item measure, with each item scored 0 to 6. Items are summed for a total score from 0 to 30. Higher scores = more craving.

Secondary outcomes

  1. EEG Theta Brainwave Activity

    Time frame: 2 weeks

    Theta event rate is examined as the number of times/second that brainwaves within the theta frequency range (4-7 Hz). Higher event rates reflect more activity during working memory task.

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

tDCS to Decrease Opioid Relapse

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2019
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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