Table 2.
Assessment | Screen | Baseline scan | Week 1 | Week 2 | Week 3 | Post-Tx scan (Week 4) | Week 6 | |
Eligibility and safety assessments | Consent form | x | ||||||
Characterisation of pain | x | |||||||
Physical examination | x | |||||||
Medical history | x | |||||||
Concomitant medications | x | x | ||||||
Adverse events | x | x | x | x | x | x | ||
C-SSRS (suicidality) | x | x | x | x | x | |||
Urine drug test (10-Panel) | x | x | x | |||||
Urine pregnancy test | x | |||||||
Serum pregnancy test | x | x | ||||||
Liver function tests | x | x | ||||||
Primary outcome | [11C]PBR28 Signal in Thalamus | x | x | |||||
Secondary outcomes | [11C]PBR28 Signal in Limbic Regions (pgACC, aMCC) | x | x | |||||
‘Worst Pain’ item of BPI-SF (0–10 scale) | Daily survey ratings from~2 weeks before scan I until Week 6 | |||||||
Pain Bothersomeness Ratings (0–10 scale) | Daily survey ratings from~2 weeks before scan I until Week 6 | |||||||
BDI-II | x | x | x | x | ||||
PGIC | x | |||||||
Exploratory outcomes | Reward Task (MID) | x | x | |||||
BPI-SF | x | x | x | x | ||||
PCS | x | x | x | x | ||||
PainDETECT | x | x | ||||||
ODI | x | x | ||||||
ACR Fibromyalgia Survey | x | x | x | |||||
Depression Ratings (0–10 scale) | Daily survey ratings from~2 weeks before scan I until week 6 | |||||||
PROMIS-29 | x | x | ||||||
PSQI | x | x | x | |||||
SymptomMapper | x | x |
BDI-II, Beck Depression Inventory; BPI-SF, Brief Pain Inventory-Short Form; MID, Monetary Incentive Delay Task; ODI, Oswestry Disability Index; PCS, Pain Catastrophizing Scale; PGIC, Patient Global Impression of Change; PROMIS-29, Patient Reported Outcomes Measurement Information System–29; PSQI, Pittsburgh Sleep Quality Index.