Table 3.

Visit Schedule for Phase 2 of POATS

		Phase 2 (visit week #)
Assessments	Final Visit Phase 1	BUP/NX Stabilization													BUP/NX Taper				Follow-Up
WEEK NUMBER ≫		1a	1b	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21	22	23	24
SCREENING ASSESSMENTS
Consent Review		X
Eligibility Review		X
Randomization		X
SAFETY ASSESSMENTS
Vital Signs	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X		X		X		X		X
Lab Tests (LFTs, Chemistry, Hematology, Urinalysis)	X																	X
Pregnancy Test	X					X				X				X				X
Adverse Event (AE) Evaluation	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X		X		X		X		X
Serious Adverse Event (SAE)Evaluation		≪Completed when necessary≫
Physical Exam	X																	X
Clinical Opiate Withdrawal Scale (COWS)	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Concomitant Treatments (including medications &psychosocial)	X	X	X	X	X	X	X	X	X	X	X	X	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	X	X	X	X	X	X	X	X				X				X
Substance Use Report Follow-up	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X		X		X		X		X
Urine Drug Screen	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X		X		X		X		X
PAIN ASSESSMENTS
Brief Pain Inventory	X					X				X				X				X				X				X
Brief Pain Inventory abbrev (if pain stratification)		X	X	X	X		X	X	X		X	X	X		X	X	X
Beck Depression Inventory II	X					X				X				X				X				X				X
SF-36	X													X												X
OTHER ASSESSMENTS
Addiction Severity Index (ASI Lite) Follow-up	X																									X
Fagerstrom Test for Nicotine Dependence	X																									X
TREATMENT PLAN
BUP/NX Induction (if applicable)		X
BUP/NX Dosing or Taper		X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Medication Accountability		X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Standard Medical Management		X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Enhanced Medical Management			2X	2X	2X	2X	2X	2X	X	X	X	X	X	X
VISIT DURATION (minutes)	120		60–90												60				30							60