Table 3 Exclusion criteria and rationale
Criterion | Rationale | Assessment | Administered By |
|---|---|---|---|
A DSM-5 diagnosis of moderate or severe SUD other than Tobacco Use Disorder. | Defines study population to assess effects of rTMS versus sham on CcUD or MtUD; Safety. | DSM-5 Checklist– Substance Related Disorders | RA/RC |
History of a serious medical disorder that would make it unsafe to participate in the study or may prevent collection of study data. | Treatment for a serious medical disorder should take precedence over this experimental treatment for SUD. | Medical and Psychiatric History | MC |
Is currently engaged in formal SUD treatment or has a planned admission to a residential treatment facility or other SUD treatment program. | To assess the effects of rTMS versus sham on CcUD or MtUD. Formal treatment for SUD would interfere with assessment of study outcomes. | Treatment Status Form | RA/RC |
Documented history of unprovoked seizure (lifetime) or any seizure in the past 6 months. | Seizure is a known risk associated with rTMS; Safety. | Medical and Psychiatric History | MC |
Documented history of brain lesion(s) and/or tumor(s). | The presence of a brain tumor or lesion might be a contraindication for TMS; Safety. | Medical and Psychiatric History | MC |
Metal implants or non-removable metal objects above the waist. | rTMS produces strong, localized magnetic field; Safety. | Medical and Psychiatric History | MC |
Current pregnancy. | While there is no available evidence to date suggesting that TMS is harmful during pregnancy, the risks of using rTMS with pregnant women are unknown. | Pregnancy and Birth Control Assessment | RA/RC/MC |
History of prior TMS treatment in lifetime. | Prior TMS exposure could unblind active and sham groups. | Medical and Psychiatric History | MC |
Current or lifetime manic or hypomanic episode. | Mania and hypomanic episodes may be worsened by TMS. | MINI; Medical and Psychiatric History | RA/RC; MC |
Current psychotic disorder. | To keep the study population more homogeneous; participant retention. | MINI; Medical and Psychiatric History | RA/RC; MC |
Current active suicidal or homicidal ideation. | Participant safety. | Medical and Psychiatric History; CHRT-SR; CHRT-CR | MC; Participant; MC |
Are a prisoner or in police custody at the time of eligibility screening. | Prisoner or police custody status would preclude engagement in the study, which involves multiple in-person treatment and follow-up visits. | Screening Checklist | RA/RC |
Previously randomized as a participant in the study. | Participants may only enroll in the study once. | Screening Checklist | RA/RC |
Unwilling or unable to follow study procedures. | Participant safety and to allow assessment of study outcomes. | Investigator Judgment | PI |