Table 1.
Schedule of study procedures and assessments
| Assessment | Frequency |
|---|---|
| GENERAL | |
| Verbal consent and pre-screening questionnaire | Pre-SCR |
| Informed Consent Form | SCR |
| Demographics | SCR |
| Inclusion/Exclusion criteria | SCR |
| Medical Release Form | SCR |
| Locator Form | BSL, then at each study visit |
| Randomization | BSL |
| SAFETY and MEDICAL ASSESSMENTS | |
| DSM-5 Diagnostic Criteria for OUD | SCR |
| Medical and Psychiatric History | SCR |
| Physical Exam & Vital Signs | SCR |
| Pregnancy and Birth Control Assessment | SCR, BSL, W 4, 8, 12, 16, 20, EOT |
| Concomitant medications | SCR, BSL, then at each study visit |
| Adverse Events and Serious Adverse Events | BSL, then at each study visit |
| Clinical Opiate Withdrawal Scale | BSL, W 2, 4, 6 |
| EFFICACY and OTHER ASSESSMENTS | |
| Urine Drug Screen (UDS) | SCR, BSL, then every 2 weeks |
| Assigned OAT - Pharmacy Abstraction | BSL, then at each study visit |
| Assigned OAT - Self-report | BSL, then at each study visit |
| Client Satisfaction Questionnaire-8 | W 4, 12, EOT |
| Treatment Entry Questionnaire | BSL |
| Health Care Climate Questionnaire | W4, 12, EOT |
| Control Preference Scale | BSL |
| CollaboRATE questionnaire | BSL, then at each study visit |
| Health Service Utilization form | BSL, W 4, 8, 12, 16, 20, EOT |
| EuroQol-5D-3L/5L | BSL, W 4, 8, 12, 16, 20, EOT |
| Health Utilities Index - III | BSL, W 4, 8, 12, 16, 20, EOT |
| Brief Pain Inventory - SF | BSL, W 6, 12, 18, EOT |
| Timeline Follow Back | BSL, then at each study visit |
| ASI-Self Report Form | SCR and EOT |
| Beck Depression Inventory - II | BSL, W 12, EOT |
| Beck Anxiety Inventory | BSL, W 12, EOT |
| Kessler Psychological Distress Scale 10 | BSL, W 12, EOT |
| Risk Behaviour Survey | BSL, W 12, EOT |
| Brief Substance Craving Scale | BSL, W 2, 4, 8, 12, 16, 20, EOT |
| TREATMENT | |
| Assigned OAT - Dosing | BSL, then W 1 to 24 |
| Medical Management | BSL, then as clinically needed |
SCR, Screening. BSL, Baseline. EOT, End of Treatment. W, week.