Actively Recruiting
Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder
Led by The University of Texas Health Science Center, Houston · Updated on 2025-05-08
75
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center, Houston
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of intermittent theta burst stimulation (iTBS) applied to two specific brain areas, the left dorsolateral prefrontal cortex (dlPFC) and dorsomedial prefrontal cortex (dmPFC), in adults with cocaine use disorder. This study aims to compare these treatments to a sham procedure to understand their impact on brain activity related to reward sensitivity and motivated attention. The study is led by The University of Texas Health Science Center in Houston and involves randomized, triple-blinded allocation. Participants will receive transcranial magnetic stimulation (TMS) using a specialized device called the MagVenture Mag Pro R30 with a Cool-B70 coil. The iTBS sessions involve bursts of electrical stimulation delivered at 110% of a resting motor threshold, lasting about 3 minutes per session. Each participant undergoes three sessions per visit with short breaks in between. Study groups receive iTBS targeting either the dlPFC, dmPFC, or a sham stimulation designed to mimic treatment without active pulses. The intensity of stimulation may be adjusted to participant tolerance. During the study, participants will complete tasks and assessments before and immediately after iTBS sessions. Researchers will measure brain electrical responses to reward and visual stimuli, craving levels, pain, cognitive function, reward learning behavior, and anhedonia using various standardized scales and tasks. Participants will be monitored for safety and adherence, with data collected to evaluate changes in these measures. The trial accommodates adults aged 18 to 65 with moderate to severe cocaine use disorder and involves a structured, short-term intervention and evaluation process.
CONDITIONS
Brief Title
Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Non-treatment-seeking individuals
- Meet DSM-5 criteria for current cocaine use disorder of at least moderate severity (4 or more symptoms)
- Have at least one positive urine Benzoylecgonine specimen (≥ 300 ng/mL) during intake
- Able to understand and provide written informed consent
- Able to provide verifiable contact information for at least two persons
You will not qualify if you...
- Current moderate or severe substance use disorder other than cocaine, marijuana, or nicotine
- Any medical, neurological, psychiatric, or physical condition that could interfere with study completion or safety
- Recent (within 3 months) suicidal or homicidal ideation or behavior posing safety concerns
- Medical implants contraindicating TMS (e.g., aneurysm clips, pacemakers, stimulators, magnetic implants) within 30 cm of the coil
- History of brain surgery or intracranial lesions or conditions causing increased intracranial pressure
- Symptoms such as frequent headaches or vision loss within 30 days of enrollment
- Moderate-to-severe heart disease or history of stroke
- Use of certain antidepressant, antipsychotic, stimulant, or seizure-risk-increasing medications within 1 week before enrollment
- Conditions of probation or parole requiring drug use reports
- Personal or first-degree family history of epilepsy or seizure disorder
- Serious head injury with loss of consciousness
- Impending incarceration
- Pregnant or nursing females
- Inability to read, write, or speak English
- For ages 18-21, any risk factor for neurocardiogenic syncope
- Hair style incompatible with EEG nets
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Multiple visits over the study period as per crossover schedule
Participants receive transcranial magnetic stimulation (TMS) targeting different brain areas in a randomized crossover design. Each visit includes 3 TMS sessions separated by 15-20 minute intervals. The stimulation sessions involve active or sham iTBS delivered at varying intensities based on participant tolerance.
3 TMS sessions per visit with intervals, multiple visits depending on assigned sequence
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
H
Heather Webber, PhD
J
Jessica Vincent
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
6
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