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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 : June 13, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Colleen A Hanlon, PhD, Medical University of South Carolina

Brief 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.

Condition or disease Intervention/treatment Phase
Cocaine Dependence Alcohol Dependence Device: Real cTBS Device: Sham cTBS Phase 2

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
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)

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).
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)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03238859


Contacts
Contact: Colleen A Hanlon, PhD 843-792-5732 hanlon@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Colleen A Hanlon, PhD    843-792-5732    hanlon@musc.edu   
Ralph H Johnson Veterans Medical Center Recruiting
Charleston, South Carolina, United States, 29425
Contact: Colleen A Hanlon, PhD    843-792-5732    hanlon@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Colleen A Hanlon, PhD Medical University of South Carolina

Responsible Party: Colleen A Hanlon, PhD, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03238859     History of Changes
Other Study ID Numbers: 00046438
R21DA041610 ( U.S. NIH Grant/Contract )
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be shared. All data is deidentified.

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

Additional relevant MeSH terms:
Alcoholism
Cocaine-Related Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents