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N-acetylcysteine + TBS for Cocaine Use Disorder (COCA Trial)

Phase 2
Recruiting
Led By Hesheng Liu, PhD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Does not have a history of claustrophobia leading to significant clinical anxiety symptoms
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 weeks
Awards & highlights

COCA Trial Summary

This trial is testing whether a combination of theta burst stimulation and N-acetylcysteine can reduce cocaine craving and change brain response to cocaine-related images.

Who is the study for?
This trial is for adults aged 18-65 with cocaine use disorder who are fluent in English and currently receiving outpatient treatment for substance issues. Participants must live within 50 miles of the study site, have no history of seizures or metal implants in the head/neck, and not be at risk for MRI-related complications like claustrophobia or certain brain injuries.Check my eligibility
What is being tested?
The trial tests whether combining theta burst stimulation (TBS) with N-acetylcysteine (NAC) can reduce cravings and alter brain responses to cocaine cues in individuals with cocaine use disorder. It aims to understand if this combination therapy is more effective than current treatments.See study design
What are the potential side effects?
Potential side effects may include discomfort at the TBS application site, headache, dizziness, nausea from NAC, and possible allergic reactions. The risks associated with MRI scans include discomfort due to loud noises or confined spaces.

COCA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have a history of claustrophobia causing severe anxiety.
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I don't have a history of seizures and am not on medication that increases seizure risk.
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I am between 18 and 65 years old.
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I have never had a severe head injury or been told I have brain bleeding.

COCA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Magnitude of change in brain functional connectivity
Magnitude of change in fMRI brain response to images from NAC
Magnitude of change in fMRI brain response to images from TBS

COCA Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Placebo + Theta Burst StimulationExperimental Treatment1 Intervention
Group II: N-acetylcysteine + Theta Burst StimulationExperimental Treatment2 Interventions
Group III: Placebo + Sham Theta Burst StimulationActive Control1 Intervention
Group IV: N-acetylcysteine + Sham Theta Burst StimulationPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N-acetylcysteine
2008
Completed Phase 4
~1290

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,469 Previous Clinical Trials
2,619,313 Total Patients Enrolled
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,539 Total Patients Enrolled
Hesheng Liu, PhDPrincipal Investigator - Medical University of SC
Medical University of South Carolina
6 Previous Clinical Trials
290 Total Patients Enrolled

Media Library

Decrease Cocaine Cue Reactivity (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04155632 — Phase 2
Cocaine Use Disorder Research Study Groups: N-acetylcysteine + Sham Theta Burst Stimulation, N-acetylcysteine + Theta Burst Stimulation, Placebo + Sham Theta Burst Stimulation, Placebo + Theta Burst Stimulation
Cocaine Use Disorder Clinical Trial 2023: Decrease Cocaine Cue Reactivity Highlights & Side Effects. Trial Name: NCT04155632 — Phase 2
Decrease Cocaine Cue Reactivity (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04155632 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still looking for volunteers to test this treatment?

"The most up-to-date information on clinicaltrials.gov suggests that this clinical trial is still looking for participants. The study was first posted on December 18th 2020 and was last edited on May 26th 2022."

Answered by AI

Does this research project allow senior citizens to participate?

"This specific clinical trial is only open to patients that are 18-65 years old, however there are 8 other trials for individuals under the age of majority and 37 trials available for seniors."

Answered by AI

For what psychological disorders is TBS commonly prescribed?

"TBS has been traditionally used to treat corneal ulceration but recent studies have shown that it can also ameliorate symptoms of acute rhinitis, acetaminophen poisoning, and other corneal diseases."

Answered by AI

What is the study's sample size?

"That is correct. The listing on clinicaltrials.gov tells us that this study, which was created on December 18th 2020, is still recruiting patients. They are looking for 96 people to participate at 1 location."

Answered by AI

What is the current research landscape surrounding Theta-burst stimulation (TBS)?

"At the moment, 40 different clinical trials are investigating Theta-burst stimulation (TBS), with 7 of those in Phase 3. Trials for Theta-burst stimulation (TBS) tend to be located in New york, although there are a total of 46 sites running these sorts of studies."

Answered by AI

Do all patients fit the screening criteria for this experiment?

"Researchers conducting this study are looking for 96 individuals that have a history of cocaine abuse and fall between the ages 18-65 age bracket."

Answered by AI

Could TBS have any negative consequences for patients if used?

"While there is some evidence of Theta-burst stimulation (TBS) being safe, as this is a phase 2 trial, there is no data currently suggesting that it is an effective intervention. Consequently, our team at Power have given it a score of 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Neurocircuit Strategy to Decrease Cocaine Cue Reactivity
Bashar Badran 2020. "Neurocircuit Strategy to Decrease Cocaine Cue Reactivity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04155632.
~14 spots leftby Nov 2024
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