10 Days of Theta Burst Stimulation as a Tool to Treat Cocaine Dependence
Condition: Cocaine Dependence; Alcohol Dependence
MeSH terms: Alcoholism; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this double-blind sham controlled study is to evaluate the effeicacy of
      continuous theta burst stimulation to the frontal pole as a tool to decrease drug cue
      reactivity and improve treatment outcomes in treatment-engaged cocaine and alcohol users. All
      participants will be randomized to receive 10 days of real or sham rTMS to the frontal pole.
      Brain imaging data and behavioral assessments will be collected at 4 time points - before
      TMS, after 10 days of TMS, 1 month follow up and 2 month follow up.
    

Detailed description: 
      Cocaine dependence is a particularly difficult substance use disorder to treat. There is
      currently a lot of scientific inertia focused on the development of novel, neural circuit
      based strategies for intervention. A prior NARC funded pilot project in non-treatment seeking
      cocaine users demonstrated that a single session of medial prefrontal cortex theta burst
      stimulation (MPFC cTBS) decreases baseline frontal-striatal activity in limbic regions and
      decreases neural responses to cocaine uses. The effects of a single session however, erode
      over the first few hours after treatment. Sustainable effects require multiple days of
      treatment. GOAL: The next steps in pursuing this as a novel treatment are to 1) apply it to
      treatment-engaged patients and 2) determine whether several sessions of cTBS will produce
      sustainable and clinically-meaningful changes in cocaine use among these patients.

      DESIGN: Treatment-engaged cocaine users and heavy alcohol users will be randomized to receive
      10 sessions of real or sham LTD-like MPFC cTBS. This will be achieved by leveraging our
      existing partnership with the MUSC Center for Drug and Alcohol Programs (CDAP) and the
      Veterans Administration Substance Abuse Treatment Center Program (SATC) - which both provide
      a 4 week intensive outpatient treatment program. MPFC cTBS will be given during weeks 2 and 3
      of the program. Functional MRI data and clinical assessments will be acquired during weeks 1,
      4, and at participant's 1 month and 2 month Accountability/Continuity visits. Hypothesis:
      real cTBS treatment will enhance clinical outcomes (Aim 1 - including retention rates, number
      of clean urine drug screens during CDAP treatment, relapse rates at 1 and 2 months) and will
      produce a sustainable decrease in neural reactivity to cocaine cues (Aim 2 - week 1 versus
      week 4, 1 month & 2 month follow ups).
    

Intervention name(s): Real cTBS; Sham cTBS
Intervention type(s): Device; Device
Intervention description(s): This will be delivered with the Magventure Magpro system; 3600 pulses with the active sham coil (double blinded using the USB key); This will be delivered with the sham Magventure Magpro system; 3600 pulses with the active sham coil (double blinded using the USB key)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment