From: Ibudilast for alcohol use disorder: study protocol for a phase II randomized clinical trial
Study visit: Procedure | Initial Screen | Med Screen | Rand. Visit | Wk 4 F/U | Wk 8 F/U | Wk 12 F/U | Wk 16 F/U |
---|---|---|---|---|---|---|---|
Informed Consent: Initial Screen | x | ||||||
Informed Consent: Experimental/Medical | x | ||||||
Adverse Childhood Experience Questionnaire (ACE) | x | ||||||
Adverse Events/Serious Adverse Events (AE/SAE) | x | x | x | x | x | ||
Alcohol Breathalyzer | x | x | x | x | x | x | |
Alcohol Dependency Scale (ADS) | x | x | x | x | |||
Alcohol Purchase Task (APT) | x | x | x | x | |||
Alcohol Use Disorders Identification Test (AUDIT) | x | ||||||
Beck Anxiety Inventory (BAI) | x | x | x | x | x | ||
Beck Depression Inventory-Revised (BDI-II) | x | x | x | x | x | ||
Birth Control Assessment | x | ||||||
Brain Imaging (if eligible) | x | ||||||
Brief Trauma Questionnaire (BTQ) | x | ||||||
Clinical Institute W/D Assessment for Alcohol (CIWA-AR) | x | x | x | x | x | ||
Columbia Suicide Severity Rating Scale (C-SSRS) | x | x | x | x | x | ||
Safety Labs CMP/CBC (blood sample) | x | x | |||||
Concomitant Medications | x | x | x | x | x | x | |
Cannabis Use Disorder Identification Test (CUDIT) | x | ||||||
Demographics | x | ||||||
Drinking Goal | x | ||||||
Drug Compliance/Accountability | x | x | x | ||||
Drug Screen (urine sample) | x | x | x | x | x | x | |
Electrocardiogram (ECG) | x | x | |||||
Fagerstrom Test for Nicotine Dependence (FTND) | x | ||||||
Family Tree Questionnaire (FTQ) | x | ||||||
Graded Chronic Pain Scale (GCPS) | x | x | x | x | |||
ImBIBe | x | x | x | x | x | ||
Inflammation and Behavior Questionnaire | x | x | x | x | |||
Insomnia Severity Index (ISI) | x | x | x | x | x | ||
Locator Form | x | ||||||
Medical History | x | ||||||
NIH Toolbox | x | x | |||||
Neuroimmune assays (blood sample) | x | x | x | x | |||
Penn Alcohol Craving Scale (PACS) | x | x | x | x | x | ||
Physical Exam | x | ||||||
Pregnancy Test (urine sample) | x | x | x | x | x | ||
Profile of Mood States (POMS) | x | x | x | x | x | ||
Readiness to Change (RTC) Ladder | x | ||||||
Reward-Relief Drinking Scale | x | ||||||
Risky Families Questionnaire | x | ||||||
Salivary Cortisol Testing | x | ||||||
Spielberger State-Trait Anxiety Scale (STAI) | x | ||||||
Structured Clinical Interview for DSM-5 (SCID-5) | x | ||||||
Subjective Distress Units Scale (SUDS) | x | ||||||
Take Control (Computer-delivered) | x | x | x | x | |||
Timeline Follow Back (TLFB) | x | x | x | x | x | x | x |
Vital Signs (including weight) | x | x | x | x | x | x | x |