Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Cocaine Use Disorder
In brief
The purpose of this study is to assess effects of intermittent theta burst stimulation (iTBS) to left dorsolateral prefrontal cortex (dlPFC) and dorsomedial prefrontal cortex (dmPFC) compared to sham on electrophysiological indices of reward sensitivity and motivated attention in adults with cocaine use disorder.
Key facts
- Study ID
- NCT05986578
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 75
- Starts
- 2024-11-08
- Expected to finish
- 2028-06-30
- Last updated by the study team
- 2025-05-08
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- non-treatment-seeking adults
- meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for current cocaine use disorder of at least moderate severity (≥ 4 symptoms)
- have at least 1 positive urine Benzoylecgonine (BE) specimen (≥ 300 ng/mL) during intake
- be able to understand the consent form and provide written informed consent
- be able to provide the following verifiable information for a minimum of 2 contact persons: full legal name,email address, local mailing address, and as applicable, home, work, and cell phone numbers
You may not qualify if…
- current DSM-5 diagnosis for substance use disorder (of at least moderate severity) other than cocaine, marijuana, or nicotine
- in the opinion of the principal investigator (PI), the presence of any medical, neurological, psychiatric, or physical condition, disease, or illness that, may: (a) compromise interfere, limit, effect or reduce the subject's ability to complete the study; or (b) adversely impact the safety of the subject or the integrity of the data
- has current or recent (within 3 months of potential enrollment) suicidal ideation, suicidal behavior, homicidal ideation or a homicidal plan sufficient to raise subject safety concerns based on the following assessments according to the PI:
- Structured Clinical Interview for DSM-5 (SCID-5)
- Columbia Suicide Severity Rating Scale (C-SSRS) Screener - Answers YES to Questions 3, 4, 5, or 6
- Assault \& Homicidal Danger Assessment Tool - Key to Danger > 1
- medical implants contraindicating TMS (i.e., aneurysm clips or coils, stents, implanted stimulators, implanted vagus nerve or deep brain stimulators, implanted electrical devices such as pacemakers or medication pumps electrodes for monitoring brain activity, cochlear implants for hearing, any magnetic implants, bullet fragments, any other metal device or object implanted in your body closer than 30 cm from the coil)
- history of brain surgery
- history of an intracranial lesion or any medical or neurological diagnosis/condition associated with increased intracranial pressure (i.e., Idiopathic Intracranial Hypertension/Pseudotumor Cerebri) OR any of the following symptoms within 30 days of enrollment: headaches > 15 days/month, loss of vision or decreased vision
- moderate-to-severe heart disease
- history of stroke
- is taking any antidepressant or antipsychotic medication at a dose above the maximum recommended dose or at a dose deemed to be potentially unsafe according to the PI; has taken any of the following medications, which are known to increase the risk of seizures, within 1 week of study enrollment; or does not agree to abstain from taking the following medications during study participation:
- clozapine137
- chlorpromazine137
- bupropion
- clomipramine hydrochloride
- amoxapine
- maprotiline hydrochloride
- diphenhydramine
- stimulants other than cocaine including the following:
- Dextroamphetamine and amphetamine
- Dextroamphetamine
- Lisdexamfetamine dimesylate
- Methamphetamine
- Methylphenidate
Where it is running
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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