Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT05974202
Eligibility Criteria:
Inclusion Criteria:
1. Age 22-65;
2. Able to give informed consent and comply with study procedures;
3. Meets DSM-5 criteria for current moderate/severe CUD and are treatment-seeking;
4. Used cocaine at least 9 days in the past 28 days, with at least weekly cocaine use;
5. Agree to no more than moderate alcohol consumption (\<15 drinks/week for men and \<8 drinks/week for women) and to avoid using amphetamine/methamphetamine and non-prescribed benzodiazepines or barbiturates; and
6. Women of childbearing potential must agree to use a method of contraception with proven efficacy and agree to not become pregnant during the study.
Exclusion Criteria:
1. Meets DSM-5 criteria for current moderate/severe major depressive episode, OCD, bipolar disorder, schizophrenia or any psychotic disorder other than transient psychosis due to substance use;
2. Hamilton Depression Rating Scale score \> 17;
3. Young Mania Rating Scale score \>10;
4. Meets DSM-5 criteria for current moderate/severe other substance use disorder (aside from tobacco use disorder; physiologic dependence on any other substance other than nicotine, including alcohol, is exclusionary);
5. Heavy weekly alcohol drinking as defined by an average of \>14 drinks/week for men or \>7 drinks/week for women on average during the past 28 days;
6. Prior alcohol, benzodiazepine, or barbiturate withdrawal that resulted in hospitalization, medical detoxification, or resulted in seizures or delirium tremens;
7. More than twice weekly use of non-prescribed medications/drugs that may change the seizure threshold, including benzodiazepines, barbiturates, GHB/GBL, amphetamines/methamphetamine;
8. Any other current DSM-5 psychiatric disorder(s) that in the investigator's judgment are unstable, would be disrupted by study procedures, or are likely to require pharmacotherapy or psychotherapy during the study period;
9. Significant current suicide risk, indicated by either: (1) "yes" response on #3, 4, or #5 on the C-SSRS and a psychiatric risk assessment indicating a moderate or high risk of suicide or (2) suicidal behavior in the past 3 months (note: non-suicidal self-injurious behavior is not exclusionary);
10. Females with a positive urine pregnancy test;
11. Clinically significant abnormal cardiac functioning per electrocardiogram (ECG) (required for any participant age 60 years and older);
12. Seizure history including: seizure disorder/epilepsy, alcohol/drug withdrawal seizure, or seizure deemed by the study physician to be related to cocaine intoxication/withdrawal (note: febrile seizures are not exclusionary)
13. Other medical conditions that are relatively contraindicated with TMS (seizure disorders, glaucoma, increased intracranial pressure, severe migraines, stroke, brain lesions, pregnancy or breast-feeding, neurodegenerative disease, meningoencephalitis, intracerebral abscess, parenchymal or leptomeningeal cancers);
14. Medications that lower seizure threshold and in the opinion of the investigator impose significant seizure risk for the individual (including bupropion, antipsychotics, lithium, anticholinergics, and tricyclic antidepressants);
15. Cognitive disorder (MMSE \<25);
16. Disqualifying response on the TMS Adult Safety Screen (TASS);
17. Implanted devices or stimulators (cardiac pacemakers, vagus nerve stimulators, spinal cord stimulators, cochlear implant);
18. Currently taking ototoxic medications (aminoglycosides, cisplatin);
19. Metal implants or paramagnetic objects in the body that prohibits MR scanning;
20. Claustrophobia that prohibits MR scanning; or
21. Legally mandated (e.g., to avoid incarceration or other penalties) to participate in SUD treatment program.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
65 Years
Study:
NCT05974202
Study Brief:
Protocol Section:
NCT05974202