Neurocircuit Strategy to Decrease Cocaine Cue Reactivity (COCA)

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 2

Conditions: Cocaine-Related Disorders

Treatments: Drug: N-acetylcysteine; Device: Theta-burst stimulation (TBS)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04155632

5P50DA046373-04 (U.S. NIH Grant/Contract)

00091981

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 4 patient groups

N-acetylcysteine + Theta Burst Stimulation

Experimental group

Treatment:

Device: Theta-burst stimulation (TBS)

Drug: N-acetylcysteine

N-acetylcysteine + Sham Theta Burst Stimulation

Sham Comparator group

Treatment:

Drug: N-acetylcysteine

Placebo + Theta Burst Stimulation

Experimental group

Treatment:

Device: Theta-burst stimulation (TBS)

Placebo + Sham Theta Burst Stimulation

No Intervention group