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Completed

NCT Number: NCT04155632

Neurocircuit Strategy to Decrease Cocaine Cue Reactivity

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.

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Key information

Conditions

Cocaine-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Past head injury or primary neurological disorder associated with MRI abnormalities, including dementia, MCI, brain tumors, epilepsy, Parkinson's disease, or demyelinating diseases
  • Any physical or intellectual disability affecting completion of assessments
  • Any contraindication to MRI
  • Current or past psychosis
  • ECT in last 6 months
  • 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.
  • Clinical Institute Withdrawal Assessment (CIWA-Ar) scale will be used to assess alcohol withdrawal. Individuals with CIWA > 8 will be excluded.
  • Individuals with unstable medical illness (e.g., hypertension, diabetes, myocardial infarction)
  • Has current suicidal ideation or homicidal ideation.
  • Has the need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications and medications for ADHD
  • Suffers from chronic migraines
  • Any physical or intellectual disability affecting completion of assessments

Treatment and study plan

N-acetylcysteine

Drug

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.

Other names: NAC

Theta-burst stimulation (TBS)

Device

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.

Primary outcomes

  1. Change in Orbitofrontal Cortex (OFC) BOLD Signal During Cocaine Cue Reactivity Task (Pre- vs. Post-TBS)

    Time frame: From baseline to immediately post-TBS

    Measured using fMRI during cocaine cue reactivity task. Percent BOLD signal change in OFC from baseline (Visit 2) to post-TBS (Visit 3). Measured using functional MRI during a cocaine cue reactivity task. The outcome reflects the change in raw BOLD signal in the orbitofrontal cortex (OFC) between baseline and post-TBS sessions. Signal change was calculated by comparing activation during cocaine-related image blocks versus neutral image blocks. Values are reported as raw BOLD signal units (not percentages).

  2. Change in POMS Score From Baseline to Post-TBS"

    Time frame: From baseline to immediately post-TBS

    Total POMS score measured before and after TBS. Higher scores indicate worse mood.

  3. Change in Cocaine Craving Rating From Baseline to Post-TBS

    Time frame: From baseline to immediately post-TBS

    Self-reported craving measured using NRS (1-10) before and after TBS. Higher scores indicate greater craving.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: COCA

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 7, 2019
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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