Table 1.
Instrument name | Purpose/domain | Baseline | Weekly | End of treatment | Follow up |
---|---|---|---|---|---|
Informed consent | Obtain informed consent | X | |||
Demographics form | Characterize sample | X | |||
History and physical examination | Assess medical problems & eligibility | X | |||
MINI interview for DSM-5 | Assess AUD and other DSM-5 psychiatric disorders | X | |||
Columbia-suicide severity rating scale: CSSRSa | Assess suicidality & eligibility | X | Week 6 | X | X |
Pregnancy test for female subjectsb | Assess for pregnancy | X | Week 6 | ||
Clinical institute withdrawal assessment of alcohol-revised: CIWA | Study eligibility, safety | X | |||
Urine drug screen tests: UDSa | Assess drug use | X | Week 6 | X | X |
Breathalyzer | Assess alcohol use (biological) | X | X | X | X |
Adverse events | Monitor AEs and safety | X | X | X | X |
Vital signs | Blood pressure and heart rate | X | X | X | |
Concurrent medications form | Monitor medications | X | X | X | X |
Medication adherence log | Assess medication compliance | X | X | ||
Urine riboflavin testa | Biomarker of medication compliance | Week 6 | X | ||
Clinician administered PTSD scale: CAPS-5a | PTSD diagnosis and symptoms (clinician rated) | X | Week 6 | X | X |
PTSD checklist: PCL-5 | PTSD symptoms (self-report) | X | X | X | X |
Timeline follow-back: TLFB | Assess alcohol use (amount and frequency) | X | X | X | X |
Obsessive compulsive drinking scale: OCDS | Measure alcohol craving | X | X | X | X |
Visual analog scale: VAS | Assess alcohol craving | X | X | X | X |
Alcohol use disorders identification test: AUDIT | Assess alcohol use and related problems | X | Month 12 | ||
Ethyl Glucuronide: EtGa | Biomarker of alcohol use | Week 6 | X | X | |
Beck depression inventory-II: BDI-lI | Measure depression | X | X | X | X |
Satisfaction questionnaire | Asses overall satisfaction | X | Month 12 | ||
Treatment services review | Monitor services utilization | X | X | X | X |
Note. Follow up = 3, 6, and 12 months following treatment.
Repeated at week 6.
Pregnancy test at baseline, before medication initiation, before neuroimaging sessions, and at week 6.