Charleston ARC Clinical Project 4- Cortical rTMS as a Tool to Change Craving and Brain Reactivity to Alcohol Cues (ARC4)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The goal of this study is to evaluate the efficacy of two promising brain stimulation treatment protocols designed to decrease the brain response to alcohol cues among heavy alcohol users.

Condition or disease	Intervention/treatment	Phase
Alcohol Dependence	Device: medial prefrontal cortex; Device: dorsolateral prefrontal cortex; Device: sham stimulation	Not Applicable

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Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: medial prefrontal cortex stimulation; Participants will receive a single session of medial prefrontal cortex stimulation using continuous theta burst stimulation	Device: medial prefrontal cortex; neuroimaging and craving will be assessed after medial prefrontal cortex stimulation
Experimental: dorsolateral prefrontal cortex stimulation; Participants will receive a single session of dorsolateral prefrontal cortex stimulation using 10 Hz stimulation	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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Criteria

Inclusion Criteria: Age 21-40; Current alcohol use greater than 20 standard drinks per week; Current DSM-5 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-5 Axis I diagnosis except Alcohol or Nicotine Use Disorder; Current use of any psychoactive substance except nicotine and marijuana or medication as evidenced by self-report or urine drug screen; History of head trauma or epilepsy; 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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Colleen A Hanlon, PhD	8437925732	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
Principal Investigator: James Prisciandaro, PhD

Sponsors and Collaborators

Medical University of South Carolina

Investigators

Principal Investigator:	Colleen A Hanlon, PhD	Medical University of South Carolina
Principal Investigator:	James Prisciandaro, PhD	Medical University of South Carolina

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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