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New treatment option for Cocaine Use Disorder
Official title Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder
ClinicalTrials.gov ID: NCT05986578
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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...
- 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...
You likely can't join 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...
- has current or recent (within 3 months of potential enrollment) suicidal ideation, suicidal behavior, homicidal ideation or a homicidal plan...
- 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
See the full eligibility criteria
- 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
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.