10 Days of Theta Burst Stimulation as a Tool to Treat Cocaine Dependence
Completed · Phase 2 · Has a placebo group
Conditions studied: Cocaine Dependence, Alcohol Dependence
In brief
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 treatment outcomes in treatment-engaged cocaine and alcohol users. All participants will be randomized to receive 10 days of real or sham rTMS to the frontal pole. Brain imaging data and behavioral assessments will be collected at 4 time points - before TMS, after 10 days of TMS, 1 month follow up and 2 month follow up.
Key facts
- Study ID
- NCT03238859
- Run by
- Medical University of South Carolina
- People needed
- 84
- Starts
- 2016-08-01
- Expected to finish
- 2019-06-07
- Last updated by the study team
- 2020-03-12
Who can join
Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Individuals from 21-65 years old currently enrolled in an intensive outpatient treatment program.
You may not qualify if…
- 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.
Where it is running
- Medical University of South Carolina — Charleston, South Carolina, United States
- Ralph H Johnson Veterans Medical Center — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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