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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
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Alcohol Dependence Device: medial prefrontal cortex Device: dorsolateral prefrontal cortex Device: sham stimulation

  Show Detailed Description

Study Design

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

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

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

Information from the National Library of Medicine

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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

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): NCT02948296


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

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