tDCS to Decrease Opioid Relapse
Condition: Opioid Dependence; Craving
MeSH terms: Opioid-Related Disorders
Study type: Interventional

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. In phase 2, the
      investigators will perform a larger randomized clinical trial (RCT) (vs. sham control) to
      address long-term neurobehavioral outcomes, including opioid relapse, craving, and sustained
      FMRI changes.
    

Detailed 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.

      In phase 2, the investigators will perform a larger RCT using the same treatment protocol in
      100 opioid dependent participants who recently initiated buprenorphine or methadone.
      Participants will be randomized to receive five sessions of tDCS+CCN priming stimulation vs.
      sham tDCS+CCN priming. Phase two will address long-term (3-month) neurobehavioral outcomes,
      including opioid relapse, craving, and sustained fMRI changes during a paradigm that
      challenges networks associated with craving (CR) and cognitive control (CCN). During the 12
      weeks of buprenorphine or methadone maintenance treatment, the investigators will examine our
      primary clinical outcome, relapse (opioid use on >4 days per month and having an opioid
      positive urine screen), as well as days of opioid use.
    

Intervention name(s): tDCS; sham tDCS
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment