NCT05986578 Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder
| NCT ID | NCT05986578 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Cocaine Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2024-11-08 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 75 participants in total. It began in 2024-11-08 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 on electrophysiological indices of reward sensitivity and motivated attention in adults with cocaine use disorder.
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
Contact & Investigator
Heather Webber, PhD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT05986578 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Cocaine Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05986578 currently recruiting?
Yes, NCT05986578 is actively recruiting participants. Contact the research team at Heather.E.Webber@uth.tmc.edu for enrollment information.
Where is the NCT05986578 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05986578 clinical trial?
NCT05986578 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Heather Webber, PhD at The University of Texas Health Science Center, Houston. The trial plans to enroll 75 participants.