Table 2.

Visit Schedule for Phase 1 of POATS

		Phase 1 (visit week #)
Assessments	Screening/Baseline Measures	BUP/NX Treatment, Initial Follow-Up Taper												Final Visit
WEEK NUMBER ≫		1a	1b	2	3	4	5	6	7	8	9	10	11	(Week 12 if treatment success, or at time of treatment failure)
SCREENING ASSESSMENTS
Informed Consent	X
Inclusion/Exclusion Criteria	X	X
Demographics	X
Randomization		X
CIDI/Substance Use Diagnosis	X
SAFETY ASSESSMENTS
Clinical Opiate Withdrawal Scale (COWS)		X	X	X	X	X		X		X				X
Medical/Psychiatric Evaluation (including physical exam)	X													Physical Exam Only
Vital Signs	X	X	X	X	X	X		X		X		X		X
Lab Tests (LFTs, Chemistry, Hematology, Urinalysis)	X													X
Pregnancy Test	X					X								X
Adverse Event (AE) Evaluation		X	X	X	X	X		X		X		X		X
Serious Adverse Event (SAE) Evaluation		≪ Completed when necessary ≫
Concomitant Treatments (including medications & psychosocial)	X	X	X	X	X	X		X		X		X		X
EFFICACY ASSESSMENTS
Craving Visual Analog Scale (VAS)	X	X	X	X	X	X		X		X		X		X
Substance Use Report-Baseline	X
Substance Use Report-Follow-up		X	X	X	X	X		X		X		X		X
Urine Drug Screen	X	X	X	X	X	X		X		X		X		X
PAIN ASSESSMENTS
Pain & Opioid Analgesic Use History	X
Brief Pain Inventory	X					X			X		X
Brief Pain Inventory abbrev (if pain stratification)		X	X	X	X
Beck Depression Inventory II	X					X				X				X
SF-36	X													X
OTHER ASSESSMENTS
Addiction Severity Index (ASI Lite)	X
Addiction Severity Index (ASI Lite) Follow-Up														X
RBS (Risk Behavior Survey)	X
CIDI/Depression & PTSD Diagnosis	X
Fagerstrom Test for Nicotine Dependence	X													X
TREATMENT PLAN
BUP/NX Induction		X
BUP/NX Dosing or Taper		X	X	X	X	X
Medication Accountability		X	X	X	X	X
Standard Medical Management		X	X	X	X	X		X		X
Enhanced Medical Management			2X	2X	2X	2X		X		X
VISIT DURATION (minutes)	240		60–90					60–90				30		120