[米国FDAが承認または認可していないデバイスの臨床試験]

Inclusion Criteria:

• Able to provide informed consent before any study-related activity, willing to comply with all study procedures, and be available for the duration of the study.
• Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for moderate-to-severe CUD and report recent cocaine use (verified by at least one positive urine drug screen (UDS) for the cocaine metabolite benzoylecgonine (BE), during intake).
• Agree (if the participant is female and of child-bearing potential) to use effective contraceptive methods, unless the participant's male partner(s) is surgically sterile (underwent vasectomy).

Acceptable contraceptives include:

1. oral contraceptives
2. contraceptive sponge
3. patch
4. double barrier (diaphragm/spermicidal or condom/spermicidal)
5. intrauterine contraceptive system
6. etonogestrel implant
7. medroxyprogesterone acetate contraceptive injection
8. complete abstinence from sexual intercourse
9. hormonal vaginal ring

Contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use.

• Women of child-bearing potential must provide negative urine pregnancy test prior to randomization.
• Be able to provide the names and contact information of at least 2 persons who can consistently locate their whereabouts

Exclusion Criteria:

• Current DSM-5 diagnosis for substance use disorder (of at least moderate severity) other than cocaine, cannabis, or nicotine or a substance Use Disorder (SUD) requiring medical detoxification (e.g., alcohol, opioid, benzodiazepine)
• Presence of any medical, neurological, psychiatric, or physical condition, disease, or illness (including psychosis and bipolar disorder) that, in the opinion of the PIs and the Certified Registered Nurse Anesthetist (CNRA)Medical Director could: (a) compromise interfere, limit, 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:

  1. Structured Clinical Interview for DSM-5 (SCID-5)
  2. Columbia-Suicide Severity Rating Scale - Answers YES to Questions 3, 4, 5, or 6
  3. Assault & Homicidal Danger Assessment Tool - Key to Danger > 1
• Any contraindications to MRI scans (metal in the body; claustrophobia). -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.

• 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 study physician; 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. clozapine
  2. chlorpromazine
  3. bupropion
  4. clomipramine hydrochloride
  5. amoxapine
  6. maprotiline hydrochloride
  7. diphenhydramine
  8. stimulants other than cocaine including the following:
  9. Dextroamphetamine and amphetamine ii. Dextroamphetamine iii. Lisdexamfetamine dimesylate iv. Methamphetamine

  v. Methylphenidate i. tramadol j. isoniazid.

• Personal history of epilepsy or seizure disorder and/or family history including a first degree relative
• Serious head injury with loss of consciousness
• Having conditions of probation or parole requiring reports of drug use to officers of the court or impending incarceration
• 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).
• Pregnant or nursing for female participants
• Inability to read, write, or speak English.