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| ID | Type | Description | Link |
|---|---|---|---|
| 5P50DA046373-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-acetylcysteine + Theta Burst Stimulation | Experimental |
| |
| N-acetylcysteine + Sham Theta Burst Stimulation | Sham Comparator |
| |
| Placebo + Theta Burst Stimulation | Experimental |
| |
| Placebo + Sham Theta Burst Stimulation | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Orbitofrontal Cortex (OFC) BOLD Signal During Cocaine Cue Reactivity Task (Pre- vs. 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). | From baseline to immediately post-TBS |
| Change in POMS Score From Baseline to Post-TBS" | Total POMS score measured before and after TBS. Higher scores indicate worse mood. | From baseline to immediately post-TBS |
| Change in Cocaine Craving Rating From Baseline to Post-TBS | Self-reported craving measured using NRS (1-10) before and after TBS. Higher scores indicate greater craving. | From baseline to immediately post-TBS |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| All Validations Passed Badran, PhD | Medical University of SC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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Only 32 were randomized and started treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Theta Burst Stimulation | Two trains of 120-second active cTBS consisted of 3-pulse bursts delivered at 5 Hz. |
| FG001 | Sham Theta Burst Stimulation | Two trains of 120-second sham cTBS consisted of 3-pulse bursts delivered at 5 Hz. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Theta Burst Stimulation | Two trains of 120-second active cTBS consisted of 3-pulse bursts delivered at 5 Hz. |
| BG001 | Sham Theta Burst Stimulation | Two trains of 120-second sham cTBS consisted of 3-pulse bursts delivered at 5 Hz. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Orbitofrontal Cortex (OFC) BOLD Signal During Cocaine Cue Reactivity Task (Pre- vs. 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). | Posted | Mean | Standard Deviation | BOLD signal | From baseline to immediately post-TBS |
|
From baseline (Visit 2) through 3 weeks post-TBS (Visit 3), including follow-up calls at 1 day, 1 week, 2 weeks, and 3 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Theta Burst Stimulation | Two trains of 120-second active cTBS consisted of 3-pulse bursts delivered at 5 Hz. |
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We only investigate a single session of cTBS in participants with CUD. Repeated cTBS sessions may produce long-lasting changes in craving and relapse prevention, which should be explored in future research.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Xiaolong Peng | Medical University of South Carolina | 8437928642 | pengxi@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 5, 2022 | Jun 30, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 25, 2022 | Jun 11, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
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| 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. |
|
| BG002 | Total | Total of all reporting groups |
| year |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Cocaine Craving Rating | Self-reported craving measured using a Numerical Rating Scale (NRS) from 1 to 10, where 1 = no craving and 10 = extreme craving. Higher scores indicate greater craving. | Mean | Standard Deviation | score on a scale |
|
| Profile of Mood States (POMS) | Profile of Mood States (POMS) total score, ranging from 0 to 200. Higher scores indicate greater mood disturbance. Subscales include tension, depression, anger, vigor, fatigue, and confusion | Mean | Standard Deviation | POMS score |
|
| OFC brain activity | Measured using fMRI during cocaine cue reactivity task. Percent signal change in orbitofrontal cortex (OFC) during cocaine vs. neutral image blocks. | Mean | Standard Deviation | Percent BOLD signal change |
|
| Sham Theta Burst Stimulation |
Two trains of 120-second sham cTBS consisted of 3-pulse bursts delivered at 5 Hz. |
|
|
| Primary | Change in POMS Score From Baseline to Post-TBS" | Total POMS score measured before and after TBS. Higher scores indicate worse mood. | Posted | Mean | Standard Deviation | POMS score | From baseline to immediately post-TBS |
|
|
|
| Primary | Change in Cocaine Craving Rating From Baseline to Post-TBS | Self-reported craving measured using NRS (1-10) before and after TBS. Higher scores indicate greater craving. | Posted | Mean | Standard Deviation | score on a scale | From baseline to immediately post-TBS |
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| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Sham Theta Burst Stimulation | Two trains of 120-second sham cTBS consisted of 3-pulse bursts delivered at 5 Hz. | 0 | 16 | 0 | 16 | 0 | 16 |
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| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |