Clinical trial NCT04155632: Neurocircuit Strategy to Decrease Cocaine Cue Reactivity
Official title: Neurocircuit Strategy to Decrease Cocaine Cue Reactivity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-11-07
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Magnitude of change in fMRI brain response to images from TBS
timeFrame: 5 weeks
measure: Magnitude of change in brain functional connectivity
timeFrame: 5 weeks
measure: Magnitude of change in fMRI brain response to images from NAC
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of SC
name: All Validations Passed Badran, PhD
role: PRINCIPAL_INVESTIGATOR
References: