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Neurocircuit Strategy to Decrease Cocaine Cue Reactivity

Phase 2
Active, not recruiting
Conditions
Cocaine-Related Disorders
Interventions
Device: Theta-burst stimulation (TBS)
Drug: N-acetylcysteine
Registration Number
NCT04155632
Lead Sponsor
Medical University of South Carolina
Brief Summary

The overarching goal of this project is to examine the effect of combining theta burst stimulation (TBS) and N-acetylcysteine (NAC) on cocaine craving and brain response to cocaine-related images.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
62
Inclusion Criteria
  1. Age 18-65 2. English fluency 4. Meet criteria for cocaine use disorder (CUD), as determined by DSM-V criteria, using the Structured Clinical Interview for DSM-V.

  2. Enrolled in an intensive outpatient treatment program (MUSC Center for Drug and Alcohol Programs Intensive Outpatient Program (CDAP-IOP) or currently engaged in treatment for substance related problems.

  3. Able to read and understand questionnaires and informed consent 7. Lives within 50 miles of the study site. 8. Is not at elevated risk of seizure (i.e., does not have a history of seizures, is not currently prescribed medications known to lower seizure threshold) 9. Does not have metal objects in the head/neck. 10. Does not have a history of traumatic brain injury, including a head injury that resulted in hospitalization, loss of consciousness for more than 10 minutes, or having ever been informed that they have an epidural, subdural, or subarachnoid hemorrhage.

  4. Does not have a history of claustrophobia leading to significant clinical anxiety symptoms.

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Exclusion Criteria
  1. Past head injury or primary neurological disorder associated with MRI abnormalities, including dementia, MCI, brain tumors, epilepsy, Parkinson's disease, or demyelinating diseases
  2. Any physical or intellectual disability affecting completion of assessments
  3. Any contraindication to MRI
  4. Current or past psychosis
  5. ECT in last 6 months
  6. Among females, pregnancy at screening will be exclusionary. Females of child bearing potential must agree to undergo a pregnancy test 72 hours prior to the fMRI scanning session and regularly before and during the medication trial. They must further agree to notify the study physician or PA if they become pregnant during the study.
  7. Clinical Institute Withdrawal Assessment (CIWA-Ar) scale will be used to assess alcohol withdrawal. Individuals with CIWA > 8 will be excluded.
  8. Individuals with unstable medical illness (e.g., hypertension, diabetes, myocardial infarction)
  9. Has current suicidal ideation or homicidal ideation.
  10. Has the need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications and medications for ADHD
  11. Suffers from chronic migraines
  12. Any physical or intellectual disability affecting completion of assessments
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Placebo + Theta Burst StimulationTheta-burst stimulation (TBS)-
N-acetylcysteine + Theta Burst StimulationTheta-burst stimulation (TBS)-
N-acetylcysteine + Theta Burst StimulationN-acetylcysteine-
N-acetylcysteine + Sham Theta Burst StimulationN-acetylcysteine-
Primary Outcome Measures
NameTimeMethod
Magnitude of change in brain functional connectivity5 weeks

Measure the effects of N-Acetylcysteine on MRI brain functional connectivity

Magnitude of change in fMRI brain response to images from NAC5 weeks

Measure the combined effects of neural stimulation and N-Acetylcysteine on brain response to drug-related cues.

Magnitude of change in fMRI brain response to images from TBS5 weeks

Measure the effects of neural stimulation on MRI brain response to drug-related cues

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Medical University of South Carolina

🇺🇸

Charleston, South Carolina, United States

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