Sponsor study identifier
interventional
49
1 country
1
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
Actual (reported)Study Completion
December 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
September 28, 2015
Actual (reported)December 2015
Actual (reported)December 2015
Actual (reported)October 20, 2016
Actual (reported)Percent Blood Oxygen-Level Dependent (BOLD) signal change in the Medial Prefrontal Cortex (MPFC)
1 hour
Self reported craving
1 hour
Percent Blood Oxygen-Level Dependent (BOLD) signal change in the Striatum
1 hour
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.
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.
Continuous Theta Burst stimulation delivered
active sham Continuous Theta Burst stimulation delivered
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
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.
Colleen A Hanlon, PhD
Medical University of South Carolina
49 participants (actual enrollment reported by the registry).
First Submitted
September 28, 2015
First Posted
October 20, 2016
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder
Single-dose of Nalmefene to Modulate Neural Alcohol Cue Reactivity
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 2015
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
July 23, 2018
Record last verified: 2018-07
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Source: ClinicalTrials.gov.
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