Using brain stimulation to improve outcomes in cocaine use disorder

Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder

This study is testing if a type of brain stimulation can help adults with cocaine addiction feel more motivated and improve their treatment outcomes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The University of Texas Health Science Center, Houston (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05986578 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of intermittent theta burst stimulation (iTBS) applied to specific areas of the brain, namely the left dorsolateral prefrontal cortex and dorsomedial prefrontal cortex, in adults diagnosed with cocaine use disorder. Participants will receive either active TMS or a sham treatment to assess changes in their brain's response to rewards and motivation. The goal is to identify electrophysiological targets that could enhance treatment for individuals struggling with cocaine addiction.

Who should consider this trial

Good fit: Ideal candidates are non-treatment-seeking adults who meet the criteria for moderate cocaine use disorder and have a positive urine test for cocaine.

Not a fit: Patients with other substance use disorders or significant medical or psychiatric conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved treatment options for individuals with cocaine use disorder.

How similar studies have performed: Other studies utilizing TMS for substance use disorders have shown promise, suggesting potential for success in this novel application.

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

Where this trial is running

Houston, Texas

• The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Heather Webber, PhD — The University of Texas Health Science Center, Houston
• Study coordinator: Heather Webber, PhD

Conditions Cocaine Use Disorder; Transcranial Magnetic Stimulation; Event-Related Potentials; Substance Use Disorder; Reward Positivity; Late Positive Potential