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

July 19, 2018 updated by: Medical University of South Carolina

The Effects of a Single Session of Real Versus Sham Theta Burst Stimulation on the Brain Response to Drug-cues

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Blood Oxygen-Level Dependent (BOLD) signal change in the Medial Prefrontal Cortex (MPFC)
Time Frame: 1 hour
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self reported craving
Time Frame: 1 hour
Tiffany Craving Scale
1 hour
Percent Blood Oxygen-Level Dependent (BOLD) signal change in the Striatum
Time Frame: 1 hour
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 28, 2015

First Submitted That Met QC Criteria

October 18, 2016

First Posted (Estimate)

October 20, 2016

Study Record Updates

Last Update Posted (Actual)

July 23, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30506

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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