Status:
RECRUITING
Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Use Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- tramadol
- isoniazid
- having conditions of probation or parole requiring reports of drug use to officers of the court
- personal history of epilepsy or seizure disorder and/or family history including a first-degree relative
- serious head injury with loss of consciousness
- impending incarceration
- pregnant or nursing for female patients
- inability to read, write, or speak English
- for adolescent aged participants (18-21 only): any risk factor for neurocardiogenic syncope (history of syncope/presyncope related to noxious stimuli, anxiety, micturition, or posture)
- hair style that is incompatible with EEG nets
Key Trial Info
Start Date :
November 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05986578
Start Date
November 8 2024
End Date
June 30 2028
Last Update
May 8 2025
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030