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10 Days of Theta Burst Stimulation as a Tool to Treat Cocaine Dependence

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ClinicalTrials.gov Identifier: NCT03238859
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : August 3, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

September 1, 2016
August 3, 2017
August 3, 2017
August 1, 2016
December 20, 2017   (Final data collection date for primary outcome measure)
Change in Drug cue reactivity [ Time Frame: Baseline visit and 1 month follow up ]
The effect of real versus sham cTBS on drug cue reactivity will be assessed by comparing the brain activity in the limbic system
Same as current
No Changes Posted
Number of Clean Urine Drug Screens [ Time Frame: 1 month and 2 month follow up ]
The effect of real versus sham cTBS on the number of clean urine drug screens will be assessed at the 1 and 2 month follow up.
Same as current
Not Provided
Not Provided
 
10 Days of Theta Burst Stimulation as a Tool to Treat Cocaine Dependence
10 Days of Medial Prefrontal Cortex Theta Burst Stimulation (MPFC cTBS) as a Tool to Improve Clinical Outcomes and Decrease Frontal-striatal Reactivity to Cues Among Treatment-engaged Cocaine and Alcohol Users
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.

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).

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Cocaine Dependence
  • Alcohol Dependence
  • Device: Real cTBS
    This will be delivered with the Magventure Magpro system; 3600 pulses with the active sham coil (double blinded using the USB key)
  • Device: Sham cTBS
    This will be delivered with the sham Magventure Magpro system; 3600 pulses with the active sham coil (double blinded using the USB key)
  • Experimental: Real cTBS
    10 days of real cTBS treatment will be given (3600 pulses to the left frontal pole as defined by EEG coordinate: FP1; 60 second pause after 1800 pulses; 110% RMT including a 30 second initial ramp period 80%-110% RMT; Magventure MagPro X100 Cool Coil).
    Intervention: Device: Real cTBS
  • Sham Comparator: Sham cTBS
    10 days of sham cTBS treatment will be given (3600 pulses to the left frontal pole as defined by EEG coordinate: FP1; 60 second pause after 1800 pulses; 110% RMT including a 30 second initial ramp period 80%-110% RMT; Magventure MagPro X100 Cool Coil).
    Intervention: Device: Sham cTBS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
March 1, 2018
December 20, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Individuals from 21-65 years old currently enrolled in an intensive outpatient treatment program.

Exclusion Criteria:

  • Participants will be excluded if they are not between 21-65 years old, have current or prior dependence (DSM-IV, because a DSM-V version of the SCID is not yet available) on prescription or psychoactive drugs other than cocaine, alcohol, or nicotine but including marijuana; past 6 month abuse of any prescription or psychoactive drugs excluding cocaine, marijuana, alcohol or nicotine, lifetime history of head injury with loss of consciousness, being pregnant or breast feeding, unstable medical illness (e.g., hypertension, diabetes, myocardial infarction), presence of ferromagnetic metal in their body, history of seizures. Additionally, to mitigate any potential risk of seizures. As mentioned above, all participants will receive the Clinical Institute Withdrawal Assessment of Alcohol (CIWAar) assessment before each TMS visit. Individuals with a CIWA score >5 will be excused from the study. All individuals with a history of medical detoxification or hospitalization for AUD (per the Assessments listed above), self-reported alcohol withdrawal seizures, or delirium tremens will be excluded from the study.
Sexes Eligible for Study: All
21 Years to 65 Years   (Adult)
No
Contact: Colleen A Hanlon, PhD 843-792-5732 hanlon@musc.edu
United States
 
 
NCT03238859
00046438
R21DA041610 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: No
Plan Description: No individual participant data will be shared. All data is deidentified.
Colleen Hanlon, Medical University of South Carolina
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Principal Investigator: Colleen A Hanlon, PhD Medical University of South Carolina
Medical University of South Carolina
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP