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Table 2 CSP#2014, VA–BRAVE study assessments

From: Rationale, design and methods of VA-BRAVE: a randomized comparative effectiveness trial of two formulations of buprenorphine for treatment of opioid use disorder in veterans

Assessment

Screening

Baseline

Randomization

Weeks 1–3

Medication-research visits

Non-medication visits

End of study visit (week 52)

Biological assessments

 Urine pregnancy test

√

√

√

 

√

 

√

 Physical exam

√

   

Week 24

 

√

 Liver and kidney function, complete blood count (CBC)

√

   

Weeks 4, 12, 24

 

√

 Electrocardiogram (EKG)

√

   

Week 24*

  

 Urine toxicology test

 

√

 

√

√

√

√

 Blood HIV, hepatitis B (HBV), and hepatitis C (HCV)

 

√

  

Week 24

 

√

 Blood buprenorphine and norbuprenorphine

 

√

  

Week 24

 

√

Interviewer administered assessments

 The MINI International Neuropsychic Interview (MINI) [39]

√

√

    

√

 Clinical Opiate Withdrawal Scale (COWS) [40]

 

*

√

*

*

*

*

Clinical Institute Withdrawal Scale (CIWA-Ar) [41]

√

*

*

*

*

*

*

 Patient Health Questionnaire-9 (PHQ-9, item 9 only) [42]

√

  

√

√

√

√

 Timeline follow-back [43]

 

√

 

√

√

√

√

 Concomitant medications

 

√

 

√

√

 

√

 Opioid craving and overdose form

 

√

 

√

√

 

√

 PEG3 (pain, enjoyment, general activity)

 

√

 

√

√

 

√

 Service utilization review form (SURF)

 

√

  

√

 

√

 HIV risk behaviors

 

√

  

Weeks 12, 24, 36

 

√

 Criminal justice involvement

 

√

  

Week 24

 

√

 Alcohol Use Disorders Identification Test (AUDIT) [44]

 

√

    

√

 Demographics and military history

 

√

     

 Modified substance use and medical history

 

√

     

 Columbia Suicide Severity Rating Scale (C-SSRS) [45]

 

√

     

 Study Medication Adherence Visual Analog Scale (VAS)

   

√

√

 

√

 Serious/adverse event

 

*

*

*

*

*

*

Self-report assessments

 Veterans Rand-12

 

√

  

√

 

√

 Patient Health Questinnaire-9 (PHQ 9)

 

√

  

Weeks 12, 24, 36

 

√

 Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

 

√

  

Weeks 12, 24, 36

 

√

 COVID-19 Questionnaire

 

√

  

Weeks 12, 24, 36

 

√

  1. √ = collected at each timepoint; * = collected only when necessary; please note some assessments are collected only during weeks indicated in the table