Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Aug 3, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called intermittent theta burst stimulation (iTBS) to see how it affects brain activity in adults struggling with cocaine use disorder. The researchers want to find out if iTBS can help improve feelings of reward and motivation compared to a placebo (a treatment that has no active ingredients). Participants will be adults aged between 18 and 65 who have been diagnosed with a moderate to severe cocaine use disorder, meaning they have experienced several symptoms related to their cocaine use.

To participate, individuals need to be non-treatment-seeking and must provide a positive urine test for cocaine. However, those with other substance use disorders, certain medical conditions, or recent suicidal thoughts are not eligible. Participants can expect to undergo brain stimulation sessions and will be closely monitored throughout the study. This research aims to better understand potential new treatments for people with cocaine use disorder, which could ultimately lead to improved help and support for those affected.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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:
• • 1. Structured Clinical Interview for DSM-5 (SCID-5)
• • 2. Columbia Suicide Severity Rating Scale (C-SSRS) Screener - Answers YES to Questions 3, 4, 5, or 6
• • 3. 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:
• • 1. clozapine137
• • 2. chlorpromazine137
• • 3. bupropion
• • 4. clomipramine hydrochloride
• • 5. amoxapine
• • 6. maprotiline hydrochloride
• • 7. diphenhydramine
• 8. stimulants other than cocaine including the following:
• • 1. Dextroamphetamine and amphetamine
• • 2. Dextroamphetamine
• • 3. Lisdexamfetamine dimesylate
• • 4. Methamphetamine
• • 5. Methylphenidate
• • 9. tramadol
• • 10. 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