The Effects of Theta Burst Stimulation on the Brain Response to Drug and Alcohol Cues
addictionTBS
The Effects of a Single Session of Real Versus Sham Theta Burst Stimulation on the Brain Response to Drug-cues
1 other identifier
interventional
49
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Sep 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Posted
Study publicly available on registry
October 20, 2016
CompletedJuly 23, 2018
July 1, 2018
1.2 years
September 28, 2015
July 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Blood Oxygen-Level Dependent (BOLD) signal change in the Medial Prefrontal Cortex (MPFC)
1 hour
Secondary Outcomes (2)
Self reported craving
1 hour
Percent Blood Oxygen-Level Dependent (BOLD) signal change in the Striatum
1 hour
Study Arms (2)
Cocaine Users
EXPERIMENTALParticipants 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.
Alcohol Users
EXPERIMENTALParticipants 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.
Interventions
Continuous Theta Burst stimulation delivered
active sham Continuous Theta Burst stimulation delivered
Eligibility Criteria
You may qualify if:
- Age 25-55
- Non-treatment seeking cocaine users (with or without comorbid alcohol use disorder)
- Current alcohol use greater than 20 standard drinks per week
- Current DSM-V 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
You may not qualify if:
- Any current DSM-V Axis I diagnosis except Alcohol, Cocaine, or Nicotine Use Disorder
- Current or past substance dependence criteria other than cocaine, marijuana, or alcohol, smoking \>1 pack of cigarettes per day
- Current use of any psychoactive substance except cocaine, nicotine, and marijuana or medications as evidenced by self-report or urine drug screen
- Current breath alcohol concentration \>0.002
- Positive urine drug screen for stimulants (including cocaine, amphetamine, methamphetamine, etc.) at the Scanning/Stimulation visits and signs of alcohol withdrawal. Based on the sensitivity of this test, this will require that the participants abstain from cocaine use for 48 hours prior to the intervention
- History of seizures or migraine headaches
- History of head trauma or epilepsy
- Violation of other magnetic resonance imaging safety measures
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Related Publications (1)
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.
PMID: 29776789DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Colleen A Hanlon, PhD
Medical University of South Carolina
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2015
First Posted
October 20, 2016
Study Start
September 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
July 23, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share