Table 1.
Core Assessment Measures.
| Measurements | Timeline (WEEK) |
||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| −1 | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 18 | |
| Demographic, medical and diagnosic assessments | |||||||||||||||
| Demographic form | X | ||||||||||||||
| MINI diagnostic interview | X | ||||||||||||||
| History & physical examination | X | ||||||||||||||
| Substance-related assessments | |||||||||||||||
| Timeline follow back (TLFB) | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
| Obsessive compulsive drinking scale (OCDS) | X | X | X | X | |||||||||||
| Alcohol use disorders identification test (AUDIT) | X | ||||||||||||||
| Clinician institute withdrawal assessment of alcohol – revised (CIWA-Ar) | X | ||||||||||||||
| Ethyl glucuronide | X | X | X | X | X | X | |||||||||
| Visual analog scales | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |
| Breathalyzer | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
| Urine drug screen | X | X | X | X | X | X | |||||||||
| Fagerstrom test for nicotine dependence | X | X | X | ||||||||||||
| Addiction Severity index – family history | X | ||||||||||||||
| Quick drinking screen | X | X | X | X | |||||||||||
| Brief addiction monitor (BAM) | X | X | X | X | |||||||||||
| Trauma and PTSD assessments | |||||||||||||||
| Clinician administered PTSD Scale for DSM-5 (CAPS-5) | X | X | X | X | |||||||||||
| PTSD checklist for DSM-5 (PCL-5) | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
| Life events checklist (LEC) | X | X | X | X | |||||||||||
| Childhood trauma questionnaire (CTQ) | X | ||||||||||||||
| Deployment risk & resiliency inventory-2 (DRRI) | X | ||||||||||||||
| Revised conflicts tactics scale (CTS2) | X | X | X | X | X | ||||||||||
| Posttraumatic cognitions inventory (PTCI) | X | X | X | X | X | X | X | X | |||||||
| Frequency of nightmares questionnaire | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |
| Health & safety monitoring | |||||||||||||||
| Adverse events | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
| Vital signs | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
| Concomitant medications form | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
| Patient health questionnaire-9 (PHQ-9) | X | X | X | X | X | X | X | X | |||||||
| Pregnancy test (Female subjects) | X | X | X | ||||||||||||
| Veterans RAND 12 item health survey (VR-12) | X | X | X | X | |||||||||||
| History of head injuries | X | X | X | X | |||||||||||
| Treatment adherence | |||||||||||||||
| Riboflavin test | X | X | X | X | |||||||||||
| Medication adherence log | X | X | X | X | X | X | X | X | X | X | X | X | |||
| Other measures | |||||||||||||||
| Neuroimaging procedures | X | X | |||||||||||||
| Self-injurious thoughts and behaviors interview (SITBI) | X | X | X | X | |||||||||||
| Insomnia severity index (ISI) | X | X | X | X | X | X | X | X | |||||||
| Difficulties in emotion regulation scale (DERS) | X | X | X | X | |||||||||||
Note. Baseline occurs at Week −1. Medication initiation occurs at Week 0. Follow-up assessment occurs at Week 18.