RECRUITING

Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder

Conditions

Cocaine Use Disorder Transcranial Magnetic Stimulation (TMS)Event-Related Potentials Substance Use Disorder Reward Positivity Late Positive Potential

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder

Quick Facts

Study Start:2024-11-06

Study Completion:2028-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05986578

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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

Inclusion Criteria

Exclusion 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 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

Contacts and Locations

Study Contact

Heather Webber, PhD

CONTACT

713-486-2723

Heather.E.Webber@uth.tmc.edu

Jessica Vincent

CONTACT

713-486-2645

Jessica.N.Vincent@uth.tmc.edu

Principal Investigator

Heather Webber, PhD

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Study Locations (Sites)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

Heather Webber, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-06

Study Completion Date2028-06-30

Study Record Updates

Study Start Date2024-11-06

Study Completion Date2028-06-30

Terms related to this study

Keywords Provided by Researchers

Transcranial Magnetic Stimulation (TMS)
Event-Related Potentials
Substance Use Disorder
Reward Positivity
Late Positive Potential

Additional Relevant MeSH Terms

Cocaine Use Disorder