Back to resultsNeurocircuit Strategy to Decrease Cocaine Cue Reactivity (COCA)
Primary Purpose
Cocaine-Related Disorders
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
N-acetylcysteine
Theta-burst stimulation (TBS)
Sponsored by
About this trial
This is an interventional basic science trial for Cocaine-Related Disorders
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:
- 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
Sites / Locations
- Medical University of South CarolinaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Sham Comparator
Experimental
No Intervention
Arm Label
N-acetylcysteine + Theta Burst Stimulation
N-acetylcysteine + Sham Theta Burst Stimulation
Placebo + Theta Burst Stimulation
Placebo + Sham Theta Burst Stimulation
Arm Description
Outcomes
Primary Outcome Measures
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
Magnitude of change in brain functional connectivity
Measure the effects of N-Acetylcysteine on MRI brain functional connectivity
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04155632
First Posted
November 5, 2019
Last Updated
March 28, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT04155632
Brief Title
Neurocircuit Strategy to Decrease Cocaine Cue Reactivity
Acronym
COCA
Official Title
Neurocircuit Strategy to Decrease Cocaine Cue Reactivity
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 18, 2020 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
N-acetylcysteine + Theta Burst Stimulation
Arm Type
Experimental
Arm Title
N-acetylcysteine + Sham Theta Burst Stimulation
Arm Type
Sham Comparator
Arm Title
Placebo + Theta Burst Stimulation
Arm Type
Experimental
Arm Title
Placebo + Sham Theta Burst Stimulation
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Other Intervention Name(s)
NAC
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Theta-burst stimulation (TBS)
Intervention Description
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 Outcome Measure Information:
Title
Magnitude of change in fMRI brain response to images from TBS
Description
Measure the effects of neural stimulation on MRI brain response to drug-related cues
Time Frame
5 weeks
Title
Magnitude of change in brain functional connectivity
Description
Measure the effects of N-Acetylcysteine on MRI brain functional connectivity
Time Frame
5 weeks
Title
Magnitude of change in fMRI brain response to images from NAC
Description
Measure the combined effects of neural stimulation and N-Acetylcysteine on brain response to drug-related cues.
Time Frame
5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bashar Badran, PhD
Phone
843-792-6076
Email
badran@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
All Validations Passed Badran, PhD
Organizational Affiliation
Medical University of SC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hesheng Liu, PhD
Phone
843-792-2528
Email
liuhe@musc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neurocircuit Strategy to Decrease Cocaine Cue Reactivity
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