Status:
COMPLETED
10 Days of Theta Burst Stimulation as a Tool to Treat Cocaine Dependence
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Dependence
Alcohol Dependence
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
Brief Summary
The goal of this double-blind sham controlled study is to evaluate the effeicacy of continuous theta burst stimulation to the frontal pole as a tool to decrease drug cue reactivity and improve treatme...
Detailed Description
Cocaine dependence is a particularly difficult substance use disorder to treat. There is currently a lot of scientific inertia focused on the development of novel, neural circuit based strategies for ...
Eligibility Criteria
Inclusion
- Individuals from 21-65 years old currently enrolled in an intensive outpatient treatment program.
Exclusion
- Participants will be excluded if they are not between 21-65 years old, have current or prior dependence (DSM-IV, because a DSM-V version of the SCID is not yet available) on prescription or psychoactive drugs other than cocaine, alcohol, or nicotine but including marijuana; past 6 month abuse of any prescription or psychoactive drugs excluding cocaine, marijuana, alcohol or nicotine, lifetime history of head injury with loss of consciousness, being pregnant or breast feeding, unstable medical illness (e.g., hypertension, diabetes, myocardial infarction), presence of ferromagnetic metal in their body, history of seizures. Additionally, to mitigate any potential risk of seizures. As mentioned above, all participants will receive the Clinical Institute Withdrawal Assessment of Alcohol (CIWAar) assessment before each TMS visit. Individuals with a CIWA score \>5 will be excused from the study. All individuals with a history of medical detoxification or hospitalization for AUD (per the Assessments listed above), self-reported alcohol withdrawal seizures, or delirium tremens will be excluded from the study.
Key Trial Info
Start Date :
August 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2019
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03238859
Start Date
August 1 2016
End Date
June 7 2019
Last Update
March 12 2020
Active Locations (2)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
2
Ralph H Johnson Veterans Medical Center
Charleston, South Carolina, United States, 29425