Clinical Study

Suboxone Treatment and Recovery Trial (STAR-T): Study Protocol for a Randomised Controlled Trial of Opioid Medication Assisted Treatment with Adjunctive Medication Management Using Therapeutic Drug Monitoring and Contingency Management

Table 3

Interventions under study groups (TDM; TAU).

InterventionRandomisation Group
TDMTAU

InductionYesYes

StabilisationYesYes

Baseline assessmentsYesYes

Estimating BUP Elimination RateYesYes

Medication educationYesYes

Emergency cardYesYes

Outpatient DOTYesNo

Outpatient medication management manualised interventionYesNo

UDS at outpatient careYesYes

Providing prescription take-home dosesContingent on
UDS & TDM (i.e., abstinence & adherence)
Contingent on
UDS only

Stepped BUP/NX-F take-home dosesYesNo

Maximum take BUP/NX-F home doses4 weeks2 weeks

TDM YesNo

Periodic study assessmentsYesYes

End of study assessmentsYesYes

Psychosocial supportYesYes

BUP: buprenorphine; DOT: directly observed treatment; UDS: urinary drug screen; TDM: therapeutic drug monitoring.