The Effects of Theta Burst Stimulation on the Brain Response to Drug &

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02939352
Study type	Interventional
Source	Medical University of South Carolina
Contact
Status	Completed
Phase	Early Phase 1
Start date	September 2014
Completion date	December 2015

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05054738` - CRP and S&A for Inpatient Veterans	N/A
Completed	`NCT02233738` - Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services	N/A
Completed	`NCT05877807` - Effect of Baclofen to Prevent Post-Traumatic Stress Disorder
Completed	`NCT00000437` - Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)	Phase 4
Completed	`NCT00536146` - The Stress-Hormone System in Alcohol-Dependent Subjects	N/A
Terminated	`NCT00890149` - Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults	Phase 2
Completed	`NCT02179749` - Mifepristone Treatment of Alcohol Use Disorder	Phase 2
Completed	`NCT01553136` - Varenicline Treatment of Alcohol Dependence in Smokers	Phase 2
Terminated	`NCT01408641` - Topiramate for Alcohol Use in Posttraumatic Stress Disorder	N/A
Completed	`NCT01389297` - Overcoming Addictions: A Randomized Clinical Trial of a Web Application Based on SMART Recovery	N/A
Completed	`NCT01760785` - Valproate for Mood Swings and Alcohol Use Following Head Injury	N/A
Completed	`NCT01113164` - Matching Genotypes and Serotonergic Medications for Alcoholism	Phase 1
Completed	`NCT00768508` - Combined Pharmacotherapies for Alcoholism	Phase 3
Completed	`NCT00127231` - Brief Therapy Intervention for Heavy/Hazardous Drinking in HIV-Positive Women	N/A
Terminated	`NCT02842528` - Cognitive Vulnerability Factors in Alcohol-dependence	N/A
Completed	`NCT00367575` - An Internet-based Intervention for Problem Drinking	N/A
Completed	`NCT00167687` - Prazosin Alcohol Dependence IVR Study	Phase 4
Completed	`NCT00223639` - New Medications to Treat Alcohol Dependence	Phase 2
Completed	`NCT00583440` - 12-step Facilitation for the Dually Diagnosed	Phase 1/Phase 2
Recruiting	`NCT00447785` - Endocrine Regulation of Energy and Fluid Supplies in Alcoholic Patients	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms