Overview

Neurocircuit Strategy to Decrease Cocaine Cue Reactivity

Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Medical University of South Carolina
Treatments:
Acetylcysteine
Cocaine
N-monoacetylcystine
Criteria
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.

5. 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.

6. 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.

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

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