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The Effects of Theta Burst Stimulation on the Brain Response to Drug and Alcohol Cues (addictionTBS)

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ClinicalTrials.gov Identifier: NCT02939352
Recruitment Status : Completed
First Posted : October 20, 2016
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:
High relapse rates among substance dependent individuals are likely due to a combination of factors that involve limbic circuits in the brain involved in craving, including vulnerability to salient cues. Emerging data suggests that non-invasive, targeted brain stimulation may be able to modulate activity in these circuits and decrease craving. The primary goal of this pilot study is to determine the extent to which a single session of continuous theta burst stimulation to the medial prefrontal cortex can attenuate limbic circuitry involved in craving among cocaine users and alcohol users. This will be tested through a double-blind,sham-controlled brain stimulation and brain imaging study in a cohort of polysubstance abusers and alcohol users.

Condition or disease Intervention/treatment Phase
Alcoholism Cocaine Addiction Drug Addiction Device: Real continuous Theta Burst Stimulation Device: Sham continuous Theta Burst Stimulation Early Phase 1

Detailed Description:
This parent protocol contains two components - one of which is targeting cocaine users, the other of which is targeting heavy alcohol users (who will also serve as an appropriate control group for the cocaine users - who typically have comorbid alcohol use disorders). All participants will receive one session of real and one session of sham (randomized) continuous theta burst stimulation (TBS).TBS is a form of non-invasive transcranial magnetic stimulation (TMS).Continuous TBS is designed to lower cortical excitability, and requires a shorter stimulation period than typical low frequency TMS. The investigators will test the hypotheses that stimulation over the medial prefrontal cortex will attenuate activity in the medial prefrontal cortex (Aim 1), using single pulse TMS in the magnetic resonance imaging scanner. Through this innovative technique it is possible to apply a single pulse of TMS to the medial prefrontal cortex and model the hemodynamic response at the stimulation site as well as monosynaptic target regions, including the striatum. The investigators will also investigate the effect of TBS on neural response to drug cues (Aim 2). The results of these aims will be further correlated with self-reported assessments of craving throughout each experimental visit. These data will be preliminary data for a subsequent R01 focused on the sustained effects of multiple sessions of TBS and their efficacy in lowering craving for extended periods of time in treatment-seekers.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Effects of a Single Session of Real Versus Sham Theta Burst Stimulation on the Brain Response to Drug-cues
Study Start Date : September 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: Cocaine Users
Participants will receive Real continuous Theta Burst Stimulation to the left frontal pole/medial prefrontal cortex. Participants will also receive Sham continuous Theta Burst Stimulation to the left frontal pole/medial prefrontal cortex.
Device: Real continuous Theta Burst Stimulation
Continuous Theta Burst stimulation delivered

Device: Sham continuous Theta Burst Stimulation
active sham Continuous Theta Burst stimulation delivered

Experimental: Alcohol Users
Participants will receive Real continuous Theta Burst Stimulation to the left frontal pole/medial prefrontal cortex. Participants will also receive Sham continuous Theta Burst Stimulation to the left frontal pole/medial prefrontal cortex.
Device: Real continuous Theta Burst Stimulation
Continuous Theta Burst stimulation delivered

Device: Sham continuous Theta Burst Stimulation
active sham Continuous Theta Burst stimulation delivered




Primary Outcome Measures :
  1. Percent Blood Oxygen-Level Dependent (BOLD) signal change in the Medial Prefrontal Cortex (MPFC) [ Time Frame: 1 hour ]

Secondary Outcome Measures :
  1. Self reported craving [ Time Frame: 1 hour ]
    Tiffany Craving Scale

  2. Percent Blood Oxygen-Level Dependent (BOLD) signal change in the Striatum [ Time Frame: 1 hour ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 25-55
  • Non-treatment seeking cocaine users (with or without comorbid alcohol use disorder)
  • Current alcohol use greater than 20 standard drinks per week
  • Current DSM-V Alcohol Use Disorder diagnosis, including the loss of control item
  • Currently not engaged in, and do not want treatment for, alcohol related problems
  • Able to read and understand questionnaires and informed consent
  • Lives within 50 miles of the study site

Exclusion Criteria [These are listed in greater detail in the CIA Core]:

  • Any current DSM-V Axis I diagnosis except Alcohol, Cocaine, or Nicotine Use Disorder
  • Current or past substance dependence criteria other than cocaine, marijuana, or alcohol, smoking >1 pack of cigarettes per day
  • Current use of any psychoactive substance except cocaine, nicotine, and marijuana or medications as evidenced by self-report or urine drug screen
  • Current breath alcohol concentration >0.002
  • Positive urine drug screen for stimulants (including cocaine, amphetamine, methamphetamine, etc.) at the Scanning/Stimulation visits and signs of alcohol withdrawal. Based on the sensitivity of this test, this will require that the participants abstain from cocaine use for 48 hours prior to the intervention
  • History of seizures or migraine headaches
  • History of head trauma or epilepsy
  • Violation of other magnetic resonance imaging safety measures
  • Current suicidal or homicidal ideation
  • Presence of ferrous metal in the body, as evidenced by metal screening and self-report
  • Severe claustrophobia or extreme obesity that preclude placement in the MRI scanner
  • For female participants, pregnancy, as evidenced by a urine pregnancy test administered on the day of the scanning session

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): NCT02939352


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Colleen A Hanlon, PhD Medical University of South Carolina

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02939352     History of Changes
Other Study ID Numbers: 30506
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Medical University of South Carolina:
Transcranial Magnetic Stimulation
Magnetic Resonance Imaging
MRI, Functional

Additional relevant MeSH terms:
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Behavior, Addictive
Alcoholism
Cocaine-Related Disorders
Substance-Related Disorders
Compulsive Behavior
Impulsive Behavior
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders