Neurocircuit Strategy to Decrease Cocaine Cue Reactivity

Cocaine-Related Disorders Clinical Trial

— COCA  

Official title:

Neurocircuit Strategy to Decrease Cocaine Cue Reactivity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04155632
• Other study ID #: 00091981
• Secondary ID: 5P50DA046373-04
• Status: Recruiting
• Phase: Phase 2
• Start date: December 18, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Medical University of South Carolina
• Contact: Bashar Badran, PhD
• Phone: 843-792-6076
• Email: badran[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cocaine-Related Disorders

Intervention

Drug:
• N-acetylcysteine
N-acetylcysteine (NAC) is a medication that is used to treat paracetamol (acetaminophen) overdose, and to loosen thick mucus in individuals with cystic fibrosis or chronic obstructive pulmonary disease. It has a long-established safety record in adults and children, with FDA approval since 1963. The side effects most commonly noted in people who take NAC by mouth include diarrhea, nausea, vomiting, and headache. These side effects are usually mild and go away even with continued use of NAC by mouth. There is also a risk of a skin reaction, such as flushing, itching, or rash. A meta-analysis of studies evaluating long-term oral treatment with NAC for prevention of chronic bronchitis found that NAC was well tolerated, with generally mild, most commonly gastrointestinal adverse effects that did not require treatment interruption.

Device:
• Theta-burst stimulation (TBS)
Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnitude of change in fMRI brain response to images from TBS	Measure the effects of neural stimulation on MRI brain response to drug-related cues	5 weeks
Primary	Magnitude of change in brain functional connectivity	Measure the effects of N-Acetylcysteine on MRI brain functional connectivity	5 weeks
Primary	Magnitude of change in fMRI brain response to images from NAC	Measure the combined effects of neural stimulation and N-Acetylcysteine on brain response to drug-related cues.	5 weeks