Charleston ARC Clinical Project 4- Cortical rTMS as a Tool to Change Craving and Brain Reactivity to Alcohol Cues (ARC4)
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ClinicalTrials.gov Identifier: NCT02948296 |
Recruitment Status
:
Recruiting
First Posted
: October 28, 2016
Last Update Posted
: October 28, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alcohol Dependence | Device: medial prefrontal cortex Device: dorsolateral prefrontal cortex Device: sham stimulation | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 66 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
Official Title: | Charleston ARC Clinical Project 4- Cortical rTMS as a Tool to Change Craving and Brain Reactivity to Alcohol Cues |
Study Start Date : | January 2016 |
Estimated Primary Completion Date : | October 2021 |
Estimated Study Completion Date : | October 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: medial prefrontal cortex stimulation
Participants will receive a single session of medial prefrontal cortex stimulation using continuous theta burst stimulation
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Device: medial prefrontal cortex
neuroimaging and craving will be assessed after medial prefrontal cortex stimulation
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Experimental: dorsolateral prefrontal cortex stimulation
Participants will receive a single session of dorsolateral prefrontal cortex stimulation using 10 Hz stimulation
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Device: dorsolateral prefrontal cortex
neuroimaging and craving will be assessed after dorsolateral prefrontal cortex stimulation
|
Sham Comparator: sham
Participants will receive a single session of sham stimulation to the medial prefrontal cortex or dorsolateral prefrontal cortex
|
Device: sham stimulation
neuroimaging and craving will be assessed after sham stimulation
|
- Percent signal change in the cortex directly stimulated [ Time Frame: immediately after the intervention ]We will compare the effect of the interventions on the amplitude of the brain response to alcohol versus beverage cues
- Changes in neurochemistry [ Time Frame: immediately after the intervention ]We will compare the effect of the interventions on the glutamate and GABA concentrations in the cortex

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Ages Eligible for Study: | 21 Years to 40 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |

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): NCT02948296
Contact: Colleen A Hanlon, PhD | 8437925732 | hanlon@musc.edu |
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 | |
Principal Investigator: James Prisciandaro, PhD |
Principal Investigator: | Colleen A Hanlon, PhD | Medical University of South Carolina | |
Principal Investigator: | James Prisciandaro, PhD | Medical University of South Carolina |
Responsible Party: | Colleen Hanlon, Dr. Colleen A Hanlon, Medical University of South Carolina |
ClinicalTrials.gov Identifier: | NCT02948296 History of Changes |
Other Study ID Numbers: |
ARC4 |
First Posted: | October 28, 2016 Key Record Dates |
Last Update Posted: | October 28, 2016 |
Last Verified: | October 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Neuroimaging data will be uploaded to the NIH neuroimaging biorepository |
Additional relevant MeSH terms:
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |