Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder

NCT05986578 | Recruiting FDA Device

• 2 other identifiers: HSC-MS-21-0813 (Main study)K01DA058765
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in the amplitude of the Reward Positivity (RewP) component in microvolts in response to feedback on the Doors Task

  The Doors Task will be used to elicit the RewP component, representing reward sensitivity. The task is a guessing game, where participants guess which door contains a reward behind it. After selecting a door, the participants are notified if they found the prize by a green arrow pointing up or if they did not find the prize by a red arrow pointing down.

  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.

  The Picture Viewing Task will be used to elicit the LPP, reflecting the motivational salience of a stimulus. During this task, participants are asked to view a slide show of images including pleasant, unpleasant, neutral, and cocaine-related images.

  Baseline(before iTBS session),immediately after iTBS session

Secondary Outcomes (5)

• Change in craving as assessed by the Minnesota Cocaine Craving Scale (MCCS)

  Baseline(before iTBS session),immediately after iTBS session

• Change in pain as assessed by the Visual Analogue Scale

  Baseline(before iTBS session),immediately after iTBS session

• Change in cognitive function as assessed by the The Montreal Cognitive Assessment (MoCA)

  Baseline(before iTBS session),immediately after iTBS session

• Change in behavioral reward learning as assessed by the Pavlovian Go/No-Go task

  Baseline(before iTBS session),immediately after iTBS session

• Change in Anhedonia as assessed by the Snaith Hamilton Pleasure Scale (SHAPS)

  Baseline(before iTBS session),immediately after iTBS session

Study Arms (6)

dlPFC then dmPFC then Sham iTBS

EXPERIMENTAL

Device: TMS to dmPFC; Device: TMS to dlPFC; Device: Sham iTBS

dmPFC then dlPFC then sham iTBS

EXPERIMENTAL

Device: TMS to dmPFC; Device: TMS to dlPFC; Device: Sham iTBS

dmPFC then sham iTBS then dlPFC

EXPERIMENTAL

Device: TMS to dmPFC; Device: TMS to dlPFC; Device: Sham iTBS

dlPFC then sham iTBS then dmPFC

EXPERIMENTAL

Device: TMS to dmPFC; Device: TMS to dlPFC; Device: Sham iTBS

sham iTBS then dlPFC then dmPFC

EXPERIMENTAL

Device: TMS to dmPFC; Device: TMS to dlPFC; Device: Sham iTBS

shami iTBS then dmPFC then dl PFC

EXPERIMENTAL

Device: TMS to dmPFC; Device: TMS to dlPFC; Device: Sham iTBS

Interventions

TMS to dmPFC DEVICE

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.

dlPFC then dmPFC then Sham iTBS; dlPFC then sham iTBS then dmPFC; dmPFC then dlPFC then sham iTBS; dmPFC then sham iTBS then dlPFC; sham iTBS then dlPFC then dmPFC; shami iTBS then dmPFC then dl PFC

TMS to dlPFC DEVICE

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.

dlPFC then dmPFC then Sham iTBS; dlPFC then sham iTBS then dmPFC; dmPFC then dlPFC then sham iTBS; dmPFC then sham iTBS then dlPFC; sham iTBS then dlPFC then dmPFC; shami iTBS then dmPFC then dl PFC

Sham iTBS DEVICE

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.

dlPFC then dmPFC then Sham iTBS; dlPFC then sham iTBS then dmPFC; dmPFC then dlPFC then sham iTBS; dmPFC then sham iTBS then dlPFC; sham iTBS then dlPFC then dmPFC; shami iTBS then dmPFC then dl PFC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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 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:
• 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 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:
• clozapine137
• chlorpromazine137
• bupropion

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Heather Webber, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: November 8, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)