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Neurocircuit Strategy to Decrease Cocaine Cue Reactivity (COCA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155632
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Hesheng Liu, Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Drug: N-acetylcysteine Device: Theta-burst stimulation (TBS) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Neurocircuit Strategy to Decrease Cocaine Cue Reactivity
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: N-acetylcysteine + Theta Burst Stimulation 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.
Other Name: NAC

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.

Sham Comparator: N-acetylcysteine + Sham Theta Burst Stimulation 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.
Other Name: NAC

Placebo Comparator: Placebo + Theta Burst Stimulation 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.

No Intervention: Placebo + Sham Theta Burst Stimulation



Primary Outcome Measures :
  1. Magnitude of change in fMRI brain response to images from TBS [ Time Frame: 5 weeks ]
    Measure the effects of neural stimulation on MRI brain response to drug-related cues

  2. Magnitude of change in brain functional connectivity [ Time Frame: 5 weeks ]
    Measure the effects of N-Acetylcysteine on MRI brain functional connectivity

  3. Magnitude of change in fMRI brain response to images from NAC [ Time Frame: 5 weeks ]
    Measure the combined effects of neural stimulation and N-Acetylcysteine on brain response to drug-related cues.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155632


Contacts
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Contact: Catherine Hubbard, PhD 843-792-2528 hubbacat@musc.edu
Contact: Hesheng Liu, PhD 843-792-2528 liuhe@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Hesheng Liu, PhD Medical University of SC

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Responsible Party: Hesheng Liu, SmartState Endowed Chair Professor of Neuroscience, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04155632    
Other Study ID Numbers: 00091981
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Acetylcysteine
Cocaine
N-monoacetylcystine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Antidotes