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Table 1 Procedures and measures administered at each study visit

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