Trials Sponsors Conditions Drugs Pricing

Conditions

Cocaine-Related Disorders

Outcome Measures

Primary Outcomes (3)

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

Study Arms (4)

N-acetylcysteine + Theta Burst Stimulation

EXPERIMENTAL

Drug: N-acetylcysteineDevice: Theta-burst stimulation (TBS)

N-acetylcysteine + Sham Theta Burst Stimulation

SHAM COMPARATOR

Drug: N-acetylcysteine

Placebo + Theta Burst Stimulation

EXPERIMENTAL

Device: Theta-burst stimulation (TBS)

Interventions

N-acetylcysteineDrug

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.

Also known as: NAC

N-acetylcysteine + Sham Theta Burst StimulationN-acetylcysteine + Theta Burst Stimulation

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

\. 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.

Sponsors & Collaborators

National Institute on Drug Abuse (NIDA)
NIHcollaborator
Medical University of South Carolina
Otherlead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Limitations and Caveats

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.

Results Point of Contact

Title: Dr. Xiaolong Peng
Organization: Medical University of South Carolina

Study Officials

All Validations Passed Badran, PhD
Medical University of SC
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

32 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: BASIC SCIENCE
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 5, 2019

First Posted

November 7, 2019

Study Start

December 18, 2020

Actual (reported)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (3)

Study Arms (4)

N-acetylcysteine + Theta Burst Stimulation

N-acetylcysteine + Sham Theta Burst Stimulation

Placebo + Theta Burst Stimulation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Placebo + Sham Theta Burst Stimulation

You may not qualify if:

Data Sharing

Source record

Documents

Locations