Table 4 Study assessments and brief description
Assessment | Description | Administered By |
|---|---|---|
Locator Form | Collects the participant’s current address, email address, and phone numbers to assist in finding participants during study participation. | RA/RC |
Phen-X Toolkit Core Tier 1 | Includes measures for demographics, BMI, HIV risk and status, and other substance use measures such as age of onset. | RA/RC |
Protocol Satisfaction Form | Provides information on the participant’s satisfaction with the study and study procedures. | Participant |
Physical Examination | Assesses whether individuals are medically stable for study inclusion. | MC |
Medical and Psychiatric History | Covers past and present health conditions to help determine eligibility and to provide baseline information. | MC |
Vital Signs | Obtaining valid measures of weight, blood pressure, and pulse. | RA/RC/MC |
Prior and Concomitant Medications | Documents all medications taken by the participant for the 30 days prior to and during screening/baseline and during the active study for safety purposes. | RA/RC/MC |
Penetration of Blind | Participants and primary study personnel are asked whether they think the participant is receiving rTMS or sham. | Participant, RA/RC, MC |
EEG | Assesses resting connectome profile as a potential treatment response biomarker. | RA/RC or EEG technician |
MINI 7.0.2 | Semi-structured interview designed to ascertain a current, past, or lifetime history of the major Axis I psychiatric disorders in DSM-5. | RA/RC |
HADS | Brief, validated instrument that screens for both depression and anxiety. | Participant |
PSQI | Brief, validated instrument that measures sleep quality. | Participant |
CHRT-SR | 16-item self-report assessment of suicidality and related thoughts and behaviors. | Participant |
CHRT-CR | Performed if a participant screens positive on the CHRT-SR. | MC |
TLFB | Used to elicit the participant’s self-reported use, quantity, and route of administration of substances of abuse. | RA/RC |
Caffeine Intake Assessment | Assesses and quantifies use of caffeinated beverages. | RA/RC |
DSM-5 SUD Symptom Checklist | Semi-structured, interviewer-administered instrument that provides current diagnoses for substance use disorders based on DSM-5 diagnostic criteria. | RA/RC |
NIDA Cannabis Use Assessment | Assesses recreational and medical cannabis use frequency over the past 12 months, including reasons for use, method of administration, and perceived harm or benefit associated with use. | Participant |
Fagerström Test for Nicotine Dependence | Assesses cigarette use and nicotine dependence. | Participant |
Cue Craving Assessment | Assesses participant’s craving level after being exposed to cocaine/methamphetamine cues and after having the rTMS/sham intervention. | RA/RC |
Actigraphy | Collects participants’ daily sleep data, including sleep latency, duration, and waking intervals. | RA/RC |
Daily Assessments | Assesses daily substance use, cravings, stress, ability to resist use, mood, and sleep quality. The survey is delivered to the participant’s mobile device via a HIPAA-compliant application. | Participant |
Urine Drug Screen | To assess several secondary outcome measures. | RA/RC |
Urine Pregnancy Test | To determine eligibility for female participants. | RA/RC |