Clinical trial NCT05986578: Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder
Official title: Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cocaine Use Disorder
Keywords: Transcranial Magnetic Stimulation (TMS)
Event-Related Potentials
Substance Use Disorder
Reward Positivity
Late Positive Potential
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-08-14
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

Primary outcomes:
measure: Change in the amplitude of the Reward Positivity (RewP) component in microvolts in response to feedback on the Doors Task
timeFrame: Baseline(before iTBS session),immediately after iTBS session
measure: Change in the amplitude of the Late Positive Potential (LPP) in microvolts in response to visual stimuli on the Picture Viewing Task.
timeFrame: Baseline(before iTBS session),immediately after iTBS session
Secondary outcomes:
measure: Change in craving as assessed by the Minnesota Cocaine Craving Scale (MCCS)
timeFrame: Baseline(before iTBS session),immediately after iTBS session
measure: Change in pain as assessed by the Visual Analogue Scale
timeFrame: Baseline(before iTBS session),immediately after iTBS session
measure: Change in cognitive function as assessed by the The Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline(before iTBS session),immediately after iTBS session
measure: Change in behavioral reward learning as assessed by the Pavlovian Go/No-Go task
timeFrame: Baseline(before iTBS session),immediately after iTBS session
measure: Change in Anhedonia as assessed by the Snaith Hamilton Pleasure Scale (SHAPS)
timeFrame: Baseline(before iTBS session),immediately after iTBS session
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Heather Webber, PhD
role: PRINCIPAL_INVESTIGATOR
References: