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

Primary Purpose

Alcoholism, Cocaine Addiction, Drug Addiction

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Real continuous Theta Burst Stimulation

Sham continuous Theta Burst Stimulation

About this trial

This is an interventional basic science trial for Alcoholism focused on measuring Transcranial Magnetic Stimulation, Magnetic Resonance Imaging, MRI, Functional

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cocaine Users

Alcohol Users

Arm Description

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.

Outcomes

Primary Outcome Measures

Percent Blood Oxygen-Level Dependent (BOLD) signal change in the Medial Prefrontal Cortex (MPFC)

Secondary Outcome Measures

Self reported craving

Tiffany Craving Scale

Percent Blood Oxygen-Level Dependent (BOLD) signal change in the Striatum

Full Information

NCT ID

NCT02939352

First Posted

September 28, 2015

Last Updated

July 19, 2018

Sponsor

Medical University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT02939352

Brief Title

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

Acronym

addictionTBS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcoholism, Cocaine Addiction, Drug Addiction

Keywords

Transcranial Magnetic Stimulation, Magnetic Resonance Imaging, MRI, Functional

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cocaine Users

Arm Type

Experimental

Arm Description

Arm Title

Alcohol Users

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Real continuous Theta Burst Stimulation

Intervention Description

Continuous Theta Burst stimulation delivered

Intervention Type

Device

Intervention Name(s)

Sham continuous Theta Burst Stimulation

Intervention Description

active sham Continuous Theta Burst stimulation delivered

Primary Outcome Measure Information:

Title

Percent Blood Oxygen-Level Dependent (BOLD) signal change in the Medial Prefrontal Cortex (MPFC)

Time Frame

1 hour

Secondary Outcome Measure Information:

Title

Self reported craving

Description

Tiffany Craving Scale

Time Frame

1 hour

Title

Percent Blood Oxygen-Level Dependent (BOLD) signal change in the Striatum

Time Frame

1 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Colleen A Hanlon, PhD

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29776789

Citation

Kearney-Ramos TE, Dowdle LT, Lench DH, Mithoefer OJ, Devries WH, George MS, Anton RF, Hanlon CA. Transdiagnostic Effects of Ventromedial Prefrontal Cortex Transcranial Magnetic Stimulation on Cue Reactivity. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 Jul;3(7):599-609. doi: 10.1016/j.bpsc.2018.03.016. Epub 2018 Apr 10.

Results Reference

derived

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

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