Recruiting

Transcranial Magnetic Stimulation

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT05986578

Conditions

Cocaine Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

TMS to dmPFC

TMS to dlPFC

Sham iTBS

Study Details

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.

Conditions

Cocaine Use Disorder

Study ID

NCT05986578

Start date

Nov 8, 2024

Status verified date

May, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: dlPFC then dmPFC then Sham iTBS

experimental: dmPFC then dlPFC then sham iTBS

experimental: dmPFC then sham iTBS then dlPFC

experimental: dlPFC then sham iTBS then dmPFC

experimental: sham iTBS then dlPFC then dmPFC

experimental: shami iTBS then dmPFC then dl PFC

Interventions

TMS to dmPFC

TMS will be delivered with a MagVenture Mag Pro R30 with the Cool-B70 A/P coil with active liquid cooling and active/sham sides. For dmPFC, approximately 25% of the nasion-inion distance or Talairah coordinates X 0 Y+60 Z+60 will be measured. The first session will begin with the acquisition of the resting motor threshold (rMT) on the contralateral hand. iTBS (triplet 50 Hz bursts, repeated at 5 Hz, 2 sec on and 8 sec off; 600 pulses per session) will be delivered at 110% of the rMT and will last \~3 minutes. The stimulation will start at a lower percentage and ramp up over time to acclimate participant to the feeling of stimulation. The intensity will be lowered in participant cannot tolerate the stimulation. Each participant will receive 3 sessions per visit with a 15-20 minute interval between sessions to increase the likelihood of detecting acute effects.

TMS to dlPFC

TMS will be delivered with a MagVenture Mag Pro R30 with the Cool-B70 A/P coil with active liquid cooling and active/sham sides. For dlPFC, position F3 will be measured, using probabilistic EEG placement. The first session will begin with the acquisition of the resting motor threshold on the contralateral hand. iTBS (triplet 50 Hz bursts, repeated at 5 Hz, 2 sec on and 8 sec off; 600 pulses per session) will be delivered at 110% of the rMT and will last 3 minutes. The stimulation will start at a lower percentage and ramp up over time to acclimate participant to the feeling of stimulation. The intensity will be lowered in participant cannot tolerate the stimulation. Each participant will receive 3 sessions per visit with a 15-20 minute interval between sessions to increase the likelihood of detecting acute effects.

Sham iTBS

Sham TMS will be delivered with the sham side of the MagVenture Cool B70 A/P coil. The software will be pre-programmed by a staff member that will not be involved in data analysis or collection for blinding purposes. The sham stimulation will match the number of pulses and length of time as the active condition and each participant will receive 3 sessions with a 15-20 min interval between sessions.

Primary outcome measure

  • Change in the amplitude of the Reward Positivity (RewP) component in microvolts in response to feedback on the Doors Task [ Time Frame: Baseline(before iTBS session),immediately after iTBS session ]
  • Change in the amplitude of the Late Positive Potential (LPP) in microvolts in response to visual stimuli on the Picture Viewing Task. [ Time Frame: Baseline(before iTBS session),immediately after iTBS session ]

Central Contacts and Locations

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

May 8, 2025

Last verified

May, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-05-08.